External (contract) resource for Notified Bodies.

Regulatory Affairs Consulting
External Resource Enquiry

  • Yes, I have an NBOG F 2014-2 that justifies my qualification for these codes

    • 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

    • 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

  • MDR Technical Documentation Assessment (any classification), MDD Design Dossiers, MDD Technical File Surveillance, Unannounced audits, QMS audits.

OUR PEOPLE

Joseph 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.”

Bio 
DEVICES

Large Joints |

Small Joints |

Extremities |

Trauma |

Limb Salvage |

Maxillofacial |

Sports Medicine |

Meniscal Repair |

Reusable Surgical Instruments |

Single Use Instruments |

Large Joints | Small Joints | Extremities | Trauma | Limb Salvage | Maxillofacial | Sports Medicine | Meniscal Repair | Reusable Surgical Instruments | Single Use Instruments |