Clients

Services Provided:

ISO 13485 Internal Audits

Internal Training: MDR and ISO 13485:2016

Services Provided:
510k Market Access Project Delivery

Services Provided:
Internal auditing – ISO 27001
Ongoing outsourced support

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Services Provided:
QMS Production support incl. Quality Manual, SOPs and Forms to ISO 13485:2016 
Technical File production support to MDR
EU Rep Service

Services Provided:
Internal Training: ISO 14971:2019
Technical File Project Support

Services Provided:
MDR Transition for Technical Files
PMS Report production
Ongoing outsourced support
EU Rep / UK RP Service

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Services Provided:

MDR Transition for Technical Files

EU Rep Service

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Services Provided:
QMS Production incl. Quality Manual, SOPs and Forms to ISO 13485:2016 

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Services Provided:
MDR Transition for Technical Files

Services Provided:

MDR Transition for QMS and Technical Files

Ongoing outsourced support

EU Rep Service

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Services Provided:
MDR Transition for Technical Files
EU Rep Service