Quality you can rely on
At Medipack in Schaffhausen, quality is not just a promise – it is an integral part of our daily work. As a specialist partner for sterile packaging solutions in the medical technology sector, we operate in accordance with the requirements of ISO EN 13485:2016, the internationally recognised standard for quality management systems for medical devices.
What does ISO EN 13485:2016 mean for us?
Verified processes – safe products
As an ISO 13485-certified company, we meet the strict regulatory requirements for the development, production and provision of services in the medical device sector. Our quality management system ensures that our packaging solutions are not only functional and efficient, but above all safe for patients and users.More about the standard
ISO EN 13485:2016 defines the requirements for a quality management system specifically tailored to the medical technology sector. It ensures that our processes are planned, documented, monitored and continuously improved on a risk-based approach – throughout the entire product lifecycle.
Why we rely on ISO 13485
Responsibility for people and markets
As a packaging specialist for sensitive medical products, we bear a high level of responsibility. ISO 13485 provides us with the framework to:- Ensure product safety and patient protection
- Meet our customers' regulatory requirements
- Support our customers' access to international markets
- Embody efficiency, traceability and transparency in all processes
- Systematically minimise risks
How our quality management system is structured
Structure and safety down to the last detail
Our quality organisation is based on the clear structures of ISO 13485. Every product and every process goes through defined and documented quality stages:- Documentation & traceability
Complete records – from raw material testing to the finished product - Responsibility & leadership
Clear responsibilities and a quality policy put into practice - Risk management
Analysis and control of all quality-related risks - Supplier management
Strict selection and ongoing evaluation of our partners - Validated processes
Every production step is verified and documented in accordance with standards - Product monitoring
Continuous testing, feedback systems and complaint management - Internal audits & continuous improvement
Regular checks and targeted further developments
Who we work for
Our customers – our responsibility
Our certified processes are specifically tailored to the high standards of our customers:- Medical device manufacturers
- OEM partners
- Contract packagers
- and international system suppliers
Whether for clinical trials or mass production – Medipack offers standards-compliant packaging solutions with maximum process reliability.
Our path to certification
ISO 13485 as a living standard
How we built our system- Systematic GAP analysis
- Establishment and maintenance of our QMS
- Training and awareness-raising for all staff
- Certification by an accredited body
- Annual surveillance audits and recertification
For us, certification is not a one-off milestone – it is part of a dynamic, practical quality system that we actively implement and develop every day.