We will advise, set up and maintain a quality management system to meet requirements of client and competent authorities.
Helping your businesses comply with ISO 13485 who already have ISO 9001 certification
We can help manufacturing businesses who already have ISO 9001 certification and need to achieve compliance with ISO 13485.
ISO 9001 and ISO 13485 have important differences. ISO 9001 was developed for application to any industry, but ISO 13485 is specifically tailored to medical device companies. It is the most common path to QMS compliance for firms registering their medical devices in Europe and other markets.