So much of today’s medical landscape, including diagnostics and all levels of treatment, rely on active medical devices. Active MDD cover all devices requiring a power source other than the body itself or gravity. Lives and health depend on the safe and accurate functioning of such instruments, and your company is dedicated to providing doctors, hospitals and paramedics with life-saving tools of the highest standard. In addition to maintaining a high level of performance internally, this means complying with external directives and regulations set forth by national and international authorities. Well-versed in the intricacies of medical device compliance worldwide, our experts offer services designed to meet your needs. Our laboratories, located across the globe, are among the most sophisticated in the world, and we provide the expertise to match.
Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.
Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.
Unlock your international success with our Market Access Services. To ensure a smooth and fast market access, we support you with all necessary certifications, inspections and regulatory researches.