Validation of Reprocessing Instructions for Medical Device Manufacturers
Validation of Reprocessing Instructions According to MDR
We support manufacturers of reusable surgical instruments in meeting the requirements of the EU Medical Device Regulation (MDR), with a focus on the preparation and validation of reprocessing instructions in accordance with DIN EN ISO 17664 for Class 1r products.
From selecting the right instruments and defining test criteria to carrying out the validation, we assist you with the expertise of our accredited chemical and microbiological laboratory. For extensive instrument portfolios, we also offer tailored database solutions for managing test results.
Your benefits with Normec
Full MDR compliance – Support with creating and validating reprocessing instructions according to DIN EN ISO 17664
Independent and accredited – Validation performed in our own DAkkS-accredited chemical and microbiological laboratory
All-in-one service – From instrument selection to reporting, all steps from a single expert partner
Tailored database solutions – Efficient result management for large instrument portfolios
Experienced team – In-depth expertise in reusable surgical instruments and regulatory requirements
Validation of Reprocessing Instructions for Medical Device Manufacturers
We support manufacturers of reusable surgical instruments in meeting the requirements of the new Medical Device Regulation (MDR) concerning the provision and validation of reprocessing instructions. These requirements relate to the information provided by the manufacturer (DIN EN ISO 17664 for Class 1r products, reusable surgical instruments).
We assist you in validating your reprocessing instructions, selecting your instruments, defining test criteria, and conducting the validation. Our expertise includes access to our chemical and microbiological laboratory. If you have a wide range of instruments, we can also provide databases for managing test results.
These services might also be of interest to you
Academy
Validation of Reprocessing Procedures
We offer manufacturer-independent validation of your reprocessing procedures using all standard devices across the entire reprocessing chain: cleaning, disinfection, packaging, and sterilization (small steam sterilizer, washer-disinfector, and RDG-E). The entire validation process is covered by the scope of our accreditation.
Hygiene inspection of ventilation and air-conditioning systems
Leading company in this service
Normec Valitech
Falkensee Germany