SERVICES

QMS

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Expertise in building, developing and implementing Quality Management Systems for Medical Device organizations (Certifications to ISO13485, Adherence to CFR 820 & other country requirements)

CE

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Management of CE certifications for Medical Devices, interaction with notified bodies, competent authorities, management and hosting of regulatory inspections

Part 4 (FDA 820)

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Proven experiences in building and demonstrating compliance to the 21 CFR Part 4 legal requirements of Good Manufacturing Practice (cGMP) for combination products in the US

Design/Risk

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Set up of Design Control/Risk Management Processes for Medical Devices 

Auditing

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Qualified supplier auditing within the Medical Device and Pharmaceutical (GMP) industries 

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Perform mock inspections pre ISO13485, FDA inspections

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Support preparation & pre-inspection

Qualified Person

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Qualified to Act as 'Person responsible for regulatory requirements (article 15 new MDR)' as per the new Medical Device regulations

Ad hoc onsite Regulatory/Quality Support

MDR/ISO:13485

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Gap Analysis, remediation plans for ISO13485:2016 standard

New Medical Devices Regulation (MDR, 2017/745) - Gap Analysis, Remediation planning & project management support

PMS/Vigilance

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Post Market Surveillance, Complaints/Vigilance set up and support

Please get in touch to find out if our services can help your company achieve more 

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+44 (0) 79317 08332

Development/Engineering

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End to end services for Design & Development of devices