External (contract ) resource for Notified Bodies.
Regulatory Affairs Consulting-
Yes, I have an NBOG F 2014-2 that justifies my qualification for these codes
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Directive:
MD 0100 General non-active, non-implantable medical devices
MD 0200 Non-active implants
MD 0400 Non-active dental devices and accessories
Regulation:
MDN 1100 Non-active implants and long term surgically invasive devices
MDN 1200 Non-active non-implantable devices
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Directive:
MD 0103 Non-active orthopaedic and rehabilitation devices
MD 0106 Non-active instruments
MD 0202 Non-active orthopaedic implants
MD 0204 Non-active soft tissue implants
MD 0401 Non-active dental equipment and instruments
MD 0403 Dental implants
Regulation:
MDN 1102 Non-active osteo- and orthopaedic implants
MDN 1103 Non-active dental implants and dental materials
MDN 1104 Non-active soft tissue and other implants
MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
MDN 1208 Non-active non-implantable instruments
MDS 1006 Reusable surgical instruments
MDS 1011 Devices in systems or procedure packs
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MDR Technical Documentation Assessment (any classification), MDD Design Dossiers, MDD Technical File Surveillance, Unannounced audits, QMS audits.
OUR PEOPLEJoseph Langley MEng CEng MTOPRA
DIRECTOR
“I love being at the cutting edge of regulation, and working with Notified Bodies is a great way to do that.”
DEVICES