Remote Services

Consultancy 

Our team is made up of experienced QA/RA professionals, each with a minimum of 20 years’ knowledge and experience. This allows us to provide practical and efficient guidance on all aspects of medical device compliance, delivering solutions that work first time, even remotely.
 
We can provide you with practical and efficient guidance in the following areas:

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▪  Regulatory compliance (e.g. MDR/IVDR/MDSAP)

▪  Risk Management

▪  Quality Management Systems

▪  Technical Documentation

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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

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.