Select Page

MDR and Biological Safety

Home 9 Biosafety 9 MDR and Biological Safety
Hearing Aids

Complying with EU Medical Device Regulation (MDR) is not optional. If you are a manufacturer, authorised representative or distributor of medical devices, you will need to ensure compliance with EU MDR.

Non-compliance with biological safety requirements can result in costly delays when designing, developing or selling a medical device. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements and ensure the biological safety of your medical device products.

The General Safety and Performance Requirements (GSPR) checklist is a mandatory document all medical device manufacturers must complete prior to an MDR audit. SAXOCON has the expertise to help you comply with paragraphs 10 and 11 from CHAPTER II, REQUIREMENTS REGARDING DESIGN AND MANUFACTURE, of this checklist.

Putting processes into place that ensure quality and safety throughout your supply chain allows you to confidently engage with notified bodies, knowing that you are in compliance or can easily become compliant with the (EC) 2017/745 (MDR) regulation.

SAXOCON is ISO 13485 certified, which means that we can serve as an approved critical supplier and help you minimise the headaches associated with regulatory compliance.

Read more about how we can help you here.