Remote Services

Technical Documentation Reviews

Are you struggling to get your technical documentation to meet the requirements of the MDR and IVDR? 

Our technical documentation review service provides flexible support by our expert team to help you evaluate and compile your existing documentation, including:

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▪  Performing a gap assessment of your existing MDD or IVD compliant technical documentation

▪  Providing solutions to fill those gaps so that you can be confident submitting your documentation

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We can also help with remediation if you have already made a submission and questions have come back.

Our remote auditing services allow our Notified Body qualified team to review your quality management system (QMS) from anywhere in the world!  

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We can host a real time audit using our online meeting software, or we can apply a desk based approach where you simply provide files and we conduct the audit.

Remote audits can be performed against a range of criteria, including MD/MDR, IVDD/IVDR, ISO 9001 and ISO 13485.

We can also conduct internal and supplier audits on your behalf.

Auditing

Bespoke Courses

Majority of our clients prefer a bespoke combination of our courses because it delivers the most value for them. 

For example, if you would like to have a combined overview of the MDR and MDSAP, no problem!

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Find out more →