Select Page

Biosafety and ISO 13485

Home 9 Uncategorized 9 Biosafety and ISO 13485

You are not alone if you have been hit by costly delays when designing and developing a medical device. Trying something new or changing an existing process brings both opportunities and costs.

As a medical device manufacturer, you must demonstrate to notified bodies that all your critical suppliers conform with the ISO 13485 quality management systems standard, according to Regulation (EC) 2017/745 (MDR).

SAXOCON is ISO 13485 certified and has the expertise to help you minimize the headaches associated with a change and maximize the possibilities. So, let us help you design or fine-tune your certified quality management system processes. A certified QMS systematizes the planning and documentation of your manufacturing procedures, improving their traceability. Better traceability, in turn, lets you catch problems early, saving time and money.