Implementing a Unique Device Identification System doesn’t have to be complicated.
Start by carrying out a simple gap assessment to put your business on the right path for success!
Buy it now!
$65.00
MDR Gap Assessment: Unique Device Identification as per Annex VI Part C
The new EU Regulations on medical devices – 745/2017 (MDR) introduces the Unique Device Identifier System (UDI) to the medical industry. Whether your company has started the transition to UDI barcodes or are looking for some direction on how to start – the UDI gap assessment can help identify where your major gaps are and steer you in the right direction of what needs to be done. The Gap Assessment contains a breakdown of Annex VI: Part C clause-by-clause. Cross reference these clauses against the current state of the business and start creating simple action items for completion today!
$65.00
The MDR Gap Assessment for UDI Implementation as per Annex VI: Part C makes the transition process to UDI barcodes easy.
This template takes Annex VI Part C and breaks down the requirements for Unique Device Identification clause-by-clause into a simple, ready-to-edit template.
Use the template and cross reference each clause of Annex VI Part C against the current state of your Quality Management System to highlight where the gaps are and what your action items are going forward.
This is perfect for doing the background work before putting a transition plan to UDI Implementation in place.
This template should be used in conjunction with the Article 27 MDR Gap Assessment for UDI Implementation to ensure you’ve covered all the requirements in the new Medical Device Regulation 2017/745.
Buy it now!
$65.00
MDR Gap Assessment: Unique Device Identification as per Annex VI Part C
The new EU Regulations on medical devices – 745/2017 (MDR) introduces the Unique Device Identifier System (UDI) to the medical industry. Whether your company has started the transition to UDI barcodes or are looking for some direction on how to start – the UDI gap assessment can help identify where your major gaps are and steer you in the right direction of what needs to be done. The Gap Assessment contains a breakdown of Annex VI: Part C clause-by-clause. Cross reference these clauses against the current state of the business and start creating simple action items for completion today!
$65.00
Scientists Sanctuary 