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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.

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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 rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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