Sterile Packaging

March 24 2026

eBook: QMSR Readiness Guide

eBook: Sterile Packaging Solutions

Inspection Readiness Guide: Quality Management System Regulation (QMSR)

Support for pre-inspection alignment, management reviews, and evaluation of suppliers, partners and development milestones.

This guide is designed for organisations operating under the new Quality Management System Regulation.

The regulatory framework has shifted from procedural confirmation to structural evaluation – this guide helps you assess whether you are ready for that shift.

August 24 2025

Case Study: Resolving a Sterile Packaging Supply Gap

Matt Derczynski

Case Studies: Sterile Packaging Solutions

Supporting Continuity through MDR Preparation

“Your responsiveness and commitment helped us navigate a complex period without disruption.”

When our long-time partner prepared for the shift from MDD to MDR, they realised that a supply gap could stall their presence in the European market.

The timing couldn’t have been worse: raw materials were scarce, sterile packaging backlogs were growing, and deadlines were closing in.

Our relationship was already based on a foundation of trust, enabling us to plan ahead together and avoid any issues from arising.

To see exactly how we did it, just fill in the form for instant access to the full case-study!

July 10 2025

Diagnostics Case Study: Elos Medtech and Sysmex-Astrego

Matt Derczynski

Case Studies: Medical Polymer Solutions

Sysmex-Astrego: From Prototype to Prize-Winning Diagnostics Solution

Background and Origins

Astrego Diagnostics AB, now Sysmex Astrego, was founded in March 2017 by a team of eight individuals, four from academia and four from the medical diagnostic industry. The business idea centred around core technology developed at Uppsala University.

Elos were contacted a few months after the company was founded, though collaboration didn’t begin in earnest until 2020. The early years were spent developing rapid prototypes and refining their technology independently before seeking manufacturing support.

Team Formation and Early Strategy

The founders of Astrego came together through a network in Uppsala, and from the outset, the team knew the main aim of their project: to develop a near-patient testing platform in the Antimicrobial Susceptibility Testing (AST) space.

The team decided to focus specifically on urinary tract infections (UTIs). This decision was driven by the prevalence of UTIs and their significant contribution to antibiotic use, making them an ideal starting point to combat antimicrobial resistance.

Collaboration with Elos Medtech

Although Astrego had initial discussions with Elos soon after founding, the real collaboration started late in 2019 when the project moved from a the feasibility phase into full-scale product development.

Elos Medtech was selected as a manufacturing partner from a shortlist of six European companies. Key deciding factors included Elos’s ability to support both small-volume prototyping and high-volume production, available production capacity, and willingness to grow alongside the startup.

Initially, Elos provided a few key parts of the diagnostic cartridge, such as the reagent reservoir, parts of the nanofluidic chip, and the top lid. Over time, Elos began supplying more components, including valves and other detailed polymer parts, and took on some assembly steps. The collaboration gradually deepened as Astrego scaled operations.

Growth, Facilities, and Production Scaling

Astrego expanded rapidly, going from producing a handful of prototypes daily to thousands of units per month. They developed and scaled their operations in parallel, to accommodate growing R&D, production, and lab needs.

The production journey included building ISO 13485 compliant processes, obtaining certifications, and eventually launching the PA-100 diagnostic system system in 2023.

In May 2022 Astrego Diagnostics was acquired by the Sysmex Corporation (Kobe, Japan) a global medical diagnostic player and changed name to Sysmex Astrego.

Recognition and Continuity

In 2024, the company received the prestigious Longitude Prize, validating their innovation and boosting visibility. Their PA-100 diagnostic system is now showcased at the Science Museum in London alongside Alexander Fleming’s discovery of penicillin.

Let’s bring your idea to market—together.

Elos Medtech is your trusted partner for product development and manufacturing solutions. From design to delivery, we offer deep expertise in development, process optimization, packaging, and regulatory support.

Tell us what you need—we’re ready to help you move forward.

March 30 2025

Sterile Packaging Solutions

Matt Derczynski

Sterile packaging, validation, and logistics solutions for Medtech companies

Partner with us to turn expertise into action. Because when time matters, experience makes all the difference.

With more than 25 years of experience in the medical technology field, Elos Sterile Solutions offers you a professional service that covers all requirements and challenges around sterile packaging of implants, instruments, consumables and other medical devices.

Market Segments

Sterile Packaging Solutions

Minimally Invasive Surgeries

Sports Medicine

Make speed your advantage

Elos Medtech’s Sterile Packaging Solutions Division, we make speed your advantage. Our pre-validated system saves up to 15 months of development time, while our 10-day throughput ensures you get to market faster—without compromising quality.

With unmatched expertise and a passion for packaging, we anticipate challenges, deliver consistent quality, and guarantee reliable lead times, so you can focus on bringing life-changing medical devices to patients—on time, every time.

Validation: More than Security

A reliable and efficient validation program creates the basis for a safe medical product and therefore also for a successful product approval. We would be pleased to advise you on all validation and quality issues.

We make a detailed examination of your every need from the beginning of our partnership, so you can be sure that we consider everything throughout the packaging development, manufacturing and distribution process.

Sterile Packaging: More than Innovation

Together with you we develop a packaging concept, which fits perfectly to your product. This includes the development of tailor-made packaging, as well as the use of our pre-validated pouch and blister solutions.

Where appropriate, we can incorporate our pre-validated solutions into your custom packaging concept, ensuring the optimal balance between customization and faster project delivery times.

Sterile packaging of medical procedure kits.

Logistics: More than Storage

Due to our experience in logistic processes for medical devices, we approach the process as a partner, not only fulfilling the regulatory and legal requirements, but also considering the time and cost efficiency of transportation from our logistics center to your final customer.

We have the expertise, capabilities and processes to support you in delivering better medical devices more efficiently, allowing you to concentrate on your core business while we take care of the rest.

Logistics solutions for medical devices.

Contact Our Team

Angelika Müller
Sales Specialist
angelika.mueller@elosmedtech.com

Martin Binder
Supply Chain Manager
martin.binder@elosmedtech.com

Martin Loferer
R&D Manager
martin.loferer@elosmedtech.com

Sofie Höchstetter
VP Sterile Solutions
sofie.hochstetter@elosmedtech.com

Let’s bring your idea to market—together.

Tap into our 25 years of experience in the medical technology field, with solutions to cover all aspects of sterile packaging for implants, instruments, consumables and other medical devices.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Sterile Packaging for Sports Medicine

Matt Derczynski

Sterile Packaging Solutions for Sports Medicine

In sports medicine, implants and instruments are designed to withstand extreme biomechanical forces while supporting rapid recovery and long-term durability. These devices often incorporate advanced materials, coatings, and precision-engineered designs, making their protection in packaging just as critical as their performance in surgery.

Sterile Packaging for Sports Medicine

Efficiency and Safety

Validation and Logistics Support

Designed for Performance and Protection

Sports medicine includes a broad range of surgical interventions, requiring specialized packaging solutions for varied device types and handling needs.

Sharp Instrument Protection

Packaging must prevent damage to sterile barriers while keeping instruments secure and easy to access in fast-paced procedures.

Shock-Absorbing Packaging for Heavy Implants

Custom foam inserts and reinforced tray systems protect implants like shoulder hemispheres from impact damage during transport and handling.

Moisture-Sensitive Suture Solutions

Barrier films, desiccants, and protective packaging prevent moisture degradation in sensitive sutures and biomaterials.

Our sterile packaging solutions ensure that these devices arrive undamaged, contaminant-free, and ready for use, whether they are implants or instruments.

And if your needs extend beyond sterile packaging for sports medicine products, we also offer complete product development and manufacturing support in this area.

Click here to learn more about our full sports medicine product development and manufacturing capabilities.

Optimized Packaging for Efficiency and Safety

Beyond protection, our packaging solutions are designed for clinical efficiency:

Intuitive tray systems – Organizing instruments and implants logically for streamlined procedures.
Sterilization compatibility – Supporting various sterilization methods to integrate into existing workflows.
Space-efficient designs – Reducing packaging footprint without compromising sterility and durability.

By designing packaging that enhances usability while maintaining compliance and protection, we help manufacturers deliver more efficient, reliable solutions for sports medicine applications.

Packaging, Validation & Logistics Support

We ensure fast, compliant, and efficient sterile packaging solutions to meet market demands:

Pre-validated sterile packaging accelerates time-to-market while ensuring regulatory compliance.
Custom packaging solutions provide specialized protection for complex sports medicine devices.
Integrated logistics and distribution streamline delivery and regulatory approvals.

Your partner for sports medicine sterile packaging

With expertise in sterile packaging, regulatory compliance, and product protection, Elos Medtech helps Medtech companies to deliver safe, high-quality sports medicine solutions with confidence.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Packaging Solutions for Minimally Invasive Surgery

Matt Derczynski

Surgical Packaging Solutions for Minimally Invasive Procedures

Minimally invasive surgical (MIS) devices place unique demands on packaging. Instruments must remain sterile, undamaged, and easily accessible in space-constrained surgical environments, while packaging must protect delicate components and enable efficient workflow integration.

Tailored MIS Packaging

Designed for Seamless Handling

Scalable to Your Needs

Surgical packaging for delicate, high-performance devices

Our specialized sterile packaging solutions ensure that long, flexible, and highly precise MIS devices are safeguarded during transport, storage, and handling, meeting the highest standards of safety and efficiency.

Tailored Packaging for MIS Devices

Many MIS instruments—including catheters, guidewires, and flexible endoscopic tools—are long, slender, and delicate, making them susceptible to bending, kinking, or damage if not properly secured.

We provide:

Extra-long sterile pouches to accommodate devices up to 1500mm in length
Ultrasonic bath rinsing options for final product cleaning before packaging
Protective inserts and tip guards to prevent lumen contamination and maintain instrument integrity

For high-value, precision devices, our packaging ensures that every component is protected and ready for use.

Sterility, usability, and surgical efficiency

MIS procedures rely on speed and precision, requiring packaging that supports seamless handling and easy access in high-pressure surgical environments. Our solutions address:

Compact and efficient opening mechanisms – Designed for tight surgical spaces, enabling single-handed or minimal-step access.
Quick device identification – Custom color coding, labeling, and organization for procedure-specific kits to ensure correct instrument selection.
Minimal particulate generation – Preventing lint, fiber shedding, or debris contamination, which is critical for instruments used in micro-incisions or deep anatomical pathways.
Sterile barrier integrity – Packaging that remains intact through multiple handling steps, ensuring sterility even when coiling, uncoiling, or preparing instruments for use.

Scalable packaging solutions for MIS products

Our sterile packaging solutions are designed to support both high- and low-volume production and are aligned with global regulatory standards:

Pre-validated Sterile Packaging for faster market entry
Custom Packaging Development tailored to device-specific needs
Scalable Manufacturing Options, from manual packaging for small batches to automated high-volume solution

By integrating protective, sterile, and user-friendly packaging into the MIS device lifecycle, we help manufacturers deliver safer, more efficient surgical solutions.

Partnering for surgical packaging solutions

With deep expertise in sterile packaging, regulatory compliance, and process optimization, we help MIS device manufacturers bring high-performance solutions to market with confidence.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Sterile Packaging Solutions for Dental Devices

Matt Derczynski

Sterile Packaging Solutions for Dental Devices

In the price-sensitive dental market, where production volumes are higher, efficiency is key. We leverage advanced automation in our sterile packaging solutions to provide cost-effective, scalable, and regulatory-compliant options for dental device manufacturers.

Optimized for Market Readiness

Comprehensive Packaging Solutions

Precision and Protection for High-Volume Dental Products

Dental packaging must not only maintain sterility but also ensure product orientation, protection from environmental factors, and ease of use in clinical settings. Our tailored solutions ensure that every packaged device is optimized for safety, efficiency, and market readiness.

Precision-Oriented Packaging

Small dental components often require precise orientation within their packaging for quick and safe retrieval. We offer solutions such as packaging tubes that ensure proper alignment, making them intuitive for clinicians to handle during procedures.

Protecting Hydrophilic Surfaces

Some dental products feature hydrophilic surfaces, making them highly sensitive to oxidation and moisture. We employ specialized protective packaging techniques, such as:

Nitrogen flushing during production to reduce oxidation risk.
Aluminum barrier bags post-sterilization to maintain surface integrity.
Custom moisture-resistant packaging solutions tailored to your product’s needs.

Automated High-Volume Packaging

With higher production volumes, we incorporate automation to maximize efficiency, precision, and cost-effectiveness. This approach ensures scalability while maintaining the highest sterility and quality standards.

Comprehensive Dental Packaging Solutions

As part of our end-to-end sterile packaging solutions, we offer:

Pre-validated sterile packaging for faster market entry
Custom packaging development tailored to unique dental devices
Regulatory-compliant packaging solutions aligned with global standards

For dental device manufacturers seeking full-service support, our expertise extends beyond packaging. Visit our Dental Device Development & Manufacturing section to explore our capabilities in product development, process optimization, and regulatory compliance.

Your trusted partner for dental packaging

With expertise in sterile packaging for high-volume dental products, we help manufacturers ensure precision, sterility, and efficiency in every package.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Sterile Packaging Solutions for Spinal Surgery

Matt Derczynski

Sterile Packaging Solutions for Spinal Procedures

Spinal surgeries demand extreme precision, with every implant and instrument playing a critical role in patient outcomes. Ensuring that these components arrive sterile, undamaged, and ready for immediate use is essential for minimizing risk during these complex procedures.

Packaging for Spinal Procedures

Optimal Usability

Custom & Pre-Validated Solutions

Sterile Packaging for Spine Surgery

Spinal implants and instrumentation present unique packaging challenges due to their size, weight, and delicate nature. We offer solutions that ensure product integrity from packaging to the operating room.

Shock-Absorbing Packaging for Heavy Components

Large and dense implants such as spinal rods require specialized packaging solutions to prevent damage during transport. We provide custom foam inserts and protective blister designs to ensure these components remain secure and undamaged throughout the supply chain.

Cleanroom Assembly & Packaging of Pedicle Screws

Pedicle screws are delicate yet high-strength implants that require careful handling and sterile containment. Our packaging solutions ensure secure positioning and easy access for surgical teams, minimizing the risk of contamination or loss.

Flexible Volume Packaging Options

Many smaller spine implant manufacturers require low-volume sterile packaging solutions. We offer manual packaging options for lot sizes as low as 2 parts, though we recommend a minimum of 20 parts per batch for efficiency. Our pre-validated packaging systems provide an affordable, scalable solution for companies with fluctuating production volumes.

Explore our CDMO offering for Spine

For spinal device manufacturers seeking full-service support, our expertise extends beyond packaging. Visit our Spine and Neurosurgery hub to explore our additional capabilities.

Optimized Usability for Demanding Surgeries

In spine surgery, where procedures can be lengthy and complex, packaging design should support quick, intuitive access to implants and instruments. We integrate:

Sterile barrier systems that ensure products remain fully protected until the moment of use.
No-touch sterile access solutions to allow direct handling with instruments, minimizing contamination risk.
Compact packaging designs that reduce space consumption in sterile fields and surgical trays.

Custom & Pre-Validated Solutions

To help spine implant manufacturers bring their products to market faster and more efficiently, we offer:

Pre-validated sterile packaging solutions – Accelerating market readiness while ensuring regulatory compliance.
Custom packaging development – Tailored designs for unique spinal implants, balancing protection, sterility, and efficiency.
Regulatory-compliant packaging solutions aligned with global standards.

With the increasing shift toward minimally invasive spine procedures, we continue to refine packaging designs that align with new surgical approaches, ensuring compact, sterile, and intuitive solutions.

Your trusted partner for spine device packaging

With expertise in spinal implant packaging, validation, and regulatory compliance, we help spine device manufacturers ensure their products are delivered sterile, protected, and ready for surgery.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Sterile Packaging for Traumatology

Matt Derczynski

Sterile Packaging Solutions for Traumatology

In trauma surgery, predictability is a luxury—surgeons must be prepared for a wide range of scenarios, often requiring multiple implant sizes and instruments on hand at any given moment. This places a heavy burden on storage and sterilization processes, making packaging efficiency a crucial factor in both hospital inventory management and OR preparation.

Designed for the OR

Customized Blister Packaging

Pre-Validated Options

Sterile Packaging When Space Matters

Our sterile packaging solutions for traumatology are designed to minimize space consumption while maintaining the highest standards of sterility, safety, and usability.

Trauma implants such as bone plates and screws are historically sold as non-sterile so hospitals can sterilize them on-site, ensuring immediate access to all required sizes. However, this approach increases logistical complexity, storage requirements, and the risk of contamination.

By offering optimized, small-format sterile packaging, we provide:

Reduced storage footprint, making it easier to stock multiple implant sizes
Efficient OR preparation, eliminating the need for last-minute sterilization
Reliable sterility and cleanliness, ensuring implants are ready for immediate use

For hospitals and surgical centers seeking greater efficiency and compliance, our solutions offer a balance between space-saving design and robust protection.

At Elos Medtech, we don’t just provide sterile packaging solutions for traumatology products—we also have expertise in supporting medical device companies in the development and manufacturing of the actual products.

Click here to learn more about our orthopedic trauma expertise.

Customized Blister Packaging for Trauma Implants

Traumatology implants, particularly small screws and plates, require specialized packaging that maintains sterility without adding unnecessary bulk. Our customized blister packaging ensures:

Secure containment of individual components to prevent loss or contamination
User-friendly opening mechanisms to facilitate quick access in high-pressure trauma situations
Sterile handling solutions, such as no-touch removal designs, that allow implants to be transferred directly to the sterile field without compromising sterility

Unlike injection-molded tube packaging, which requires high production volumes, our cost-efficient blister designs can be adapted for both small and large production runs, making them ideal for traumatology applications with varied product demand.

Pre-Validated and Custom Packaging Options

To keep pace with the evolution of trauma surgery, we offer both pre-validated sterile packaging solutions and customized design.

Pre-Validated Blister Packaging – Ideal for faster time-to-market, offering regulatory-compliant, off-the-shelf solutions.
Custom Packaging Development – Tailored for complex trauma implants, ensuring a balance of protection, usability, and sterility.
Regulatory-compliant packaging solutions aligned with global standards.

By integrating cleanroom manufacturing, validation, and logistics, we provide a full-service packaging solution that simplifies trauma implant handling and storage.

Your trusted partner for trauma device packaging.

With extensive experience in medical packaging and regulatory compliance, we support trauma device manufacturers and healthcare providers in delivering safe, sterile, and space-efficient solutions.

Tell us what you need—we’re ready to help you move forward.

March 4 2025

Medical Device Packaging Design

Matt Derczynski

Medical Device Packaging Design

We are experts in anticipating, identifying and solving your medical device packaging challenges, engineering solutions to suit the end-use of the product. This careful focus complements our pre-validated off-the-shelf packaging solutions.

Our Approach

Clinical Workflow Optimization

Pre-Validated or Custom

Production Volumes

Our strategic approach to packaging development

Every medical device has unique packaging requirements throughout its lifecycle. Our approach ensures that your packaging solution is optimized for protection, efficiency, and ease of use.

Our development process includes:

Understanding your product needs and regulatory requirements
Exploring and agreeing on creative design solutions
In-house blister production for rapid development
Sample packaging for evaluation and testing
Qualification and validation of the final packaging design

To maximize efficiency, we align custom designs with our pre-validated sealing seam shapes, allowing for rapid project completion while still enabling an individualized packaging solution.

Usability is at the forefront of every design—we ensure that packaging is intuitive, easy to open even with gloves, and tailored to clinical workflows.

Designing for clinical workflows

During the design phase we consider the end-use of the solution, taking care to optimized designs to support medical professionals in their critical work.

Small-Format Packaging for Space Efficiency

Sterile-packed products can consume significant storage space in warehouses and OR setups, especially small products like screws.

Our smallest blister packaging formats minimize volume consumption while ensuring the highest standards of sterility and cleanliness. This provides a compact, practical solution for space-constrained hospital environments without compromising reliability.

No-Touch Sterile Access

Maintaining sterility during product removal is a critical challenge. Conventional packaging designs can expose the product to contamination, by requiring direct touching or the placement of the item on a surface.

We offer an innovative solution that enables direct, instrument-based removal from the packaging. For example, a screwdriver can directly engage with the sterile product inside the blister, ensuring aseptic handling without additional transfer steps.

Injection-molded tubes can also be used to minimize contamination risk. While these are ideal for some products, they require a higher production volume and can be costly to customize. Our IP-protected blister design offers a cost-efficient alternative that can be produced for both low and high volumes.

Custom and off-the-shelf packaging solutions

Our packaging engineering team works closely with clients to develop tailor-made solutions while also providing cost-effective, pre-validated packaging options.

We help find the right balance between customized and off-the-shelf components, ensuring that each project benefits from the most efficient and cost-effective approach.

Packaging for different production volumes

We offer flexible packaging processes that accommodate both low- and high-volume production:

Manual Packaging – Ideal for small batch sizes, as low as two parts per lot.
Fully Automated FFS (Form-Fill-Seal) Blister Packaging – A high-volume solution where the blister is formed, filled, sealed, printed, and cut in a single process.

By adapting the packaging process to the needs of each project, we help optimize production costs while maintaining efficiency and compliance.

Partnering for Packaging Innovation

With expertise spanning product development, process optimization, packaging, and regulatory compliance, we are the trusted partner for life science companies seeking advanced, validated, and efficient medical device packaging solutions.

Tell us what you need—we’re ready to help you move forward.