CASE STUDY:

JiT (Just in Time) Certification for ISO 13485

For European market access, medical devices need to comply with European regulations (93/42/EEC) to ensure that they are safe and perform well. ECM is designated to review the compliance of products to the essential requirements of the MDD for access to the EU market. ECM provides a complete range for services to help you bring your medical device to market quickly and efficiently.

ECM’s global team medical device experts works with you to bring your medical device to global markets, complying with international regulations and assuring product quality and safety.