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Active Implantable Medical Devices Directive (AIMD)

ce mark active implantable pacemakerHigh tech devices, such as pacemakers, cochlear implants and radioactive brachytherapy seeds, can have a dramatic impact on patient care.

Given the surgical procedure involved and integration of a source of energy (electrical or not), such devices have to go through an intense amount of scrutiny to assure safety.

Challenges

Devices covered by the Active Implantable Medical Devices (AIMD) rules are treated as Class 3 devices which require a thorough assessment procedure. AIMDs calls upon the general requirements of harmonized standard EN 45502 as well as requirements to a specific family of device types.

Not all Notified Bodies are recognized under directive 90/385/EEC (revised by the directive 2007/47/EC) to certify such devices.

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager