A Technology-First Approach to Validation.
Our Validation Team leverages Medistri's laboratory & sterilisation infrastructure to work with you and determine the most suitable process for your product to demonstrate compliance with the relevant ISO standards.
Mitigate risks. Improve your product's safety. Strengthen your Supply Chain.
Validation of ethylene oxide sterilisation
Prior to commencing routine ethylene oxide sterilization, a product with a sterility claim must undergo a validation process to 'ensure that the claimed level of sterility assurance is met.
The globally harmonized standard for validation is ANSI/AAMI/ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Learn more about Medistri's sterilization validation services ➝
Steam Sterilisation Validation
Medistri offers a complete validation of your products for steam sterilisation according to ISO17665. The validation includes physical and microbiological qualification processes. Our experts aggregate all data, present the results and recommend risk management proposals in a transparent, detailed and accurate manner.
Validation of packaging stems from the need to ensure the quality of products across the many steps of your distribution cycle: from shipping to storage.
Fully validate your packaging system or should you simply test one particular characteristic, Medistri laboratory is accredited for the most common test methods provided in ISO 11607-1
Fully validate your packaging with Medistri ➝
A fully integrated stack of services.
Medistri is continually innovating our in-house range of services. We’re expanding our services to offer a complete integrated suite of solutions for innovative healthcare companies. Organisations of every size — from startups to large enterprises use our suit of services to grow & optimise their business.
Medistri combines all its technical infrastructure and places quality at the heart of our day-to-day operations. Allowing you to simplify your supply chain management and focus on growth.
Discover how our customers use Medistri's stack of integrated services ➝
Leveraging our infrastructure
Manufacturers should have a high degree of confidence that their manufacturing processes have appropriate controls in place to produce products that are safe and meet specified user, technical and regulatory requirements. The US FDA and ISO 13485 require device manufacturers to verify that their products meet documented design specifications, which can be accomplished through inspection or post-production testing.
As a GMP/BPF accredited and FDA certified laboratory in Switzerland with many years of experience, we can support you in method development, validation and routine testing of analyses as part of your cleaning validation. We test for you according to regulatory guidelines or your own specifications.
Solutions anchored in the data.
The Medistri validation team has the following areas of expertise:
- Sterilisation validation for complex products/devices.
- Sterilisation validation for pharmaceutical products.
- Initial design of the microbiological process.
- Microbiological testing.
- Material selection.
- Dose mapping.
- Verification of doses.
- Qualification of products in the process of being CE marked.
- Reduction of incubation time for biological indicators.
- Calibration of equipment.
- Reduction of residual time.
- Qualification for the installation of equipment.
Complex Medical Devices need to assess the biocompatibility of their medical device materials and processes by taking a risk-based approach to their biological safety evaluations. Join a growing number of innovative healthcare companies that are using Medistri’s Biocompatibility testing performed according to ISO-10993.
Contract Sterilisation Services
Medistri’s sterilisation infrastructure was engineered to allow you to save time and distribute your products on the market faster. We have optimised our sterilisation processes to provide you with the fastest sterilisation services available to date.
Our Quality Certificates
Explore our list of quality certificates and discover why the world's most innovative healthcare companies choose to work with Medistri.
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