We are a team of expert medical device consultants with years of experience in the medical device research & development and medical device regulatory with specialty in CE Marking requirements for medical devices.
Our team of experts can work directly with your technical team and quality management staff to implement the essential requirements of the Medical Device Directive, 93/42/EEC.
Our combined medical device experience include:
In depth understanding of the Essential Requirements of the EU Medical Device Directive, 93/42/EEC
Compliance design to IEC 60601 series standards on basic safety and essential performance
Medical device quality management system (ISO 13485)
Medical device risk assessment (ISO 14971)
Therapeutic surface, wound care, rapid infusion pump, diagnostic imaging, vision correction laser system and more
Notified Body (NB) and other regulatory agency direct experience
We understand the difficulty on meeting the CE marking requirements under the EU Medical device Directive, 93/42/EEC.
Our goal is to provide you, a medical device manufacturer, clarity and expert guidance on the essential requirements of the EU Medical Device Directive, 93/42/EEC. We can help.