MDR / IVDR transition
Dozens of documents to rework. Consistency to keep.
MAC assesses your existing files against the MDR or IVDR, tells you what needs to be reworked, document by document, and checks that everything stays consistent until submission.
The points My Audit Corner raised are exactly the ones worth discussing. We no longer start from a blank page as in a classic audit.
You are also: MD / IVD manufacturer · Medtech start-up
What you face
A transition, not a mere formality.
GSPR, clinical evaluation, post-market surveillance, EUDAMED: every file has to be reworked in depth.
When dozens of documents change in parallel, overall consistency is lost: data corrected here remains wrong there.
Some rules change: a class error can call the whole clinical strategy into question.
Transition dates are fixed and notified bodies are overloaded. A rejected file means a blocked product.
What MAC does for you
A controlled transition, file by file.
An MDR or IVDR gap per file
MAC checks each existing file against the new requirements and produces the action plan, with the content to add.
See it in the platformConsistency checked continuously
When a document changes, MAC reassesses everything it touches: GSPR, risks, clinical, IFU, labelling.
Classification and applicable requirements
MAC checks the class under the new rules and identifies the requirements and standards that apply.
A QMS aligned with the regulation
Your quality system is assessed against ISO 13485 and the MDR or IVDR requirements.
See it in the platformA checked submission
Before sending, MAC goes through the complete file and flags missing documents, signatures or data.
A huge time saver: gaps are detected very, very quickly.
Services
Would you rather we did it for you?
Our experts deliver the service, with the platform as their engine. You pay for the outcome, not the hours.
Your questions, answered.
Does MAC cover the IVDR?
Yes: medical devices (MDR 2017/745) and in vitro diagnostic devices (IVDR 2017/746).
Our MDD files are old and scattered.
MAC reads your documents where they are, including scanned ones, and rebuilds the overall picture. There is nothing to migrate.
What happens once the transition is done?
MAC carries on: it keeps your files up to date and follows standards and your post-market commitments.
See the MDR gap of your files in a few hours.
30 minutes with our team: you connect your documentation and MAC produces its first analyses.