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Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting.

Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards.

For device manufacturers, compliance with ISO 13485, US FDA, European, Canadian, and Japanese regulations can be challenging and conducting proper internal audits is a big part of maintaining compliance.

ANSWERED ON THIS PAGE: How do we involve our entire team in the ISO 13485:2016 implementation process? What do our employees need to know about ISO 13485:2016 to maintain compliance? Is there an efficient, cost-effective way to train our team on the QMS system?

In today's fast changing and increasingly complex regulatory environment, many companies are choosing to outsource some medical device regulatory affairs and quality assurance tasks as a way to ensure quality system and regulatory compliance.

ANSWERED ON THIS PAGE: Why do we need ISO 13485 certification? How will ISO 13485 certification benefit our company? What is involved in the implementation process?