Validation Services
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.
Sterilisation Validation
EO Sterilisation Validation
Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met.
The globally harmonised standard that provides guidance for completing such validation is ANSI/AAMI/ISO 11135:2014, Sterilisation of health care products – Ethylene oxide – Requirements for development, validation, and routine control of a sterilisation process for medical devices.
Learn more about Medistri's Sterilisation Validation Services ➝
Steam Sterilisation Validation
Medistri offers complete validation of your products for steam sterilisation according to ISO 17665. The validation integrates physical and microbiological qualification processes. Our experts aggregate all data, outline findings and recommend risk management proposals in a transparent, detailed and precise manner.
Packaging Validation
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 ➝
Leverage our Infrastructure
Process Validation
Manufacturers should have a high degree of certainty that their manufacturing processes have the proper 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 makers to verify that their products meet documented design specifications, and this may be accomplished through post-production inspection or testing.
Cleaning Validation
As a GMP-accredited and FDA-certified test laboratory in Switzerland with many years of experience, we can provide you with support in method development, validation and routine testing of the analyses as part of your cleaning validation. We will test for you in following the regulatory guidelines or your own specifications.
Solutions rooted in data.
Medisitri’s Validation team presents the following fields of expertise:
- Sterilisation validation for complex combined products/ devices.
- Sterilisation validation for pharmaceutical products.
- Initial microbiological process design.
- Microbiological testing.
- Selection of Materials.
- Dose Mapping.
- Dose Verification.
- Product qualification for soon-to-be CE marked products.
- Reduction of Biological Indicators incubation time.
- Equipment Calibration.
- Reduction of Residual Time.
- Qualification for the installation of equipment.
Biocompatibility Testing
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.
Are you ready to get started?
Contact us and our qualified team will respond.