The Right Vendor Can Derisk Medical Device Packaging

Selecting the right partner for medical device packaging is not just a business decision, it’s a matter of patient safety, regulatory compliance, and long-term reliability. At Van der Stähl Scientific, we understand that every seal, every test, and every validation step contribute to protecting patients from exposure to non-sterile devices. With over 30 years of experience serving medical device manufacturers worldwide, we have built a reputation for precision, innovation, and trust.

Why the Right Vendor Matters

Medical device packaging is a critical link between manufacturing and patient care. A single failure in sterile packaging can compromise product integrity and patient safety. Choosing a vendor with proven expertise and robust support systems helps manufacturers reduce risk, maintain compliance, and ensure consistent performance.

Van der Stähl Scientific’s systems are engineered to deliver sterile packaging that meets the highest standards of reliability and repeatability. Our patented sealing technologies and validation support programs are designed to help manufacturers meet FDA and ISO requirements with confidence.

Proven Expertise and Global Reach

For more than three decades, Van der Stähl Scientific has partnered with medical device manufacturers across the globe. Our patented sterile device packaging solutions ensure that patients never encounter non-sterile devices. This commitment to safety and precision has made us a trusted name in the industry. Our experience spans thousands of successful installations and validations, each tailored to meet the unique needs of our clients. Whether you’re a startup seeking initial validation support or an established manufacturer optimizing production, our systems scale to your requirements.

ISO 17025 Calibration Laboratory

Our ISO 17025 accredited calibration laboratory provides precise calibration services for sealing equipment, ensuring that every machine operates within validated parameters. This level of accuracy supports compliance with regulatory standards and enhances process reliability.

Calibration is not just a technical requirement—it’s a cornerstone of quality assurance. By maintaining traceable calibration records, we help manufacturers demonstrate compliance during audits and maintain confidence in their sterile packaging processes.

ISO 17025 Empirical Medical Pouch Testing Services

Beyond calibration, our ISO 17025 empirical medical pouch testing services provide data-driven insights into seal integrity and sterile barrier performance. These tests validate that packaging meets or exceeds ASTM and ISO standards, offering manufacturers empirical proof of quality. Our testing protocols include peel strength, visual, and dye penetration analysis—each designed to confirm that seals maintain integrity under real-world conditions. This empirical approach ensures that packaging performs consistently from production to point of use.

The Sterile Start™ Program

To support manufacturers at every stage of their validation journey, Van der Stähl Scientific offers the Sterile Start™ Program, a tiered system providing three levels of validation support:

• Level 1: Foundational Validation Support – Ideal for startups or small manufacturers seeking initial validation guidance.
• Level 2: Intermediate Validation Support – Includes in-depth testing, documentation, and calibration assistance.
• Level 3: Advanced Validation Support – Comprehensive validation partnership with full empirical testing, calibration, and audit-ready documentation.

Each level is designed to meet specific regulatory and operational needs, helping manufacturers achieve compliance efficiently and confidently.

Innovation That Drives Confidence

Our packaging systems are built for precision and durability. With converter-matched seals, in-process visual inspection capability, and consistent seal strength, our technology empowers manufacturers to maintain sterile integrity while improving production efficiency.

We combine engineering excellence with real-world validation data to ensure that every seal meets the gold standard for sterile barrier testing. This commitment to innovation helps our clients stay ahead of competitors and emerging market trends.

Global Leadership in Sterile Packaging

Van der Stähl Scientific continues to lead the industry through innovation, compliance, and customer support. Our systems are trusted by medical device manufacturers worldwide who rely on our expertise to protect their products and patients.

We don’t just sell equipment—we provide a partnership built on trust, data, and proven performance. Our goal is to help you derisk your packaging process and strengthen your position in a competitive marketplace.

Frequently Asked Questions (FAQ)

Q1: What makes Van der Stähl Scientific different from other packaging vendors?

Our exclusive focus on medical device packaging, ISO 17025 accredited laboratory services, and patented sealing technologies set us apart. We provide end-to-end validation support and empirical testing to ensure compliance and reliability.

Q2: How does the Sterile Start™ Program help manufacturers?

The program offers three levels of validation support tailored to your needs—from foundational guidance to full empirical testing and audit-ready documentation.

Q3: Why is ISO 17025 accreditation important?

ISO 17025 accreditation ensures that our calibration and testing services meet internationally recognized standards for accuracy and reliability, giving manufacturers confidence in their validation data. We are an important partner for ISO 13485 firms.

Q4: What types of testing are included in your empirical pouch testing services?

We perform peel strength, visual, and dye penetration tests to verify seal integrity and sterile barrier performance under real-world conditions.

Q5: How long has Van der Stähl Scientific been serving the medical device industry?

We have been serving medical device manufacturers worldwide for over 30 years, providing innovative sterile packaging solutions that protect patients and ensure compliance.

Van der Stähl Scientific is known for customer service that is akin to a country store. From delivering the highest level of medical device packaging technology into the industry, reorders are one of the largest parts of our business from satisfied customers who know the value of our machinery and love the easy connection to our customer care and technology group. When you have a question, someone picks up the phone, no AI, no telephone cul-de-sacs, just an actual human on the phone. This makes all the difference to our customers in a critical process with time-sensitive projects.

We hope to serve your medical device company we’d love for you to pick up the phone and give us a call we love to talk medical device packaging 800-550-3854.