Medical  Device  &  QA  Consultancy

Product Safety / Design Control

We offer a complete Design Control Service in the form of a total partnership arrangement, covering the following aspects...     · Product Approvals   · Product Development   · Product Safety

Design Output - effective Verification and Validation of design output data is important, to minimize the cost of Design Changes, after Product is Transferred to Manufacturing...

Design Input - accurate identification of relevant Regulatory, Standard and Safety Specific Specified Requirements is essential

Risk Management - in accordance with EN 14971:2001 is fundamental to producing a finished product that meets your Customers and your Company's requirements and is in Compliance with the Regulatory Requirements....more.. 

Other Design Control information... 

Design Control in some form or other is a mandatory requirement for all Medical Devices, whether to meet the Medical Device Directive's (93/42/EEC) requirements in Europe or the FDA's cGMP Quality System Regulations for Premarket Notifications (510(k))'s in North America.

In Europe Design Control / Design Verification is required for all Classes of Device.

This includes Class I Devices where a Formal Quality System is not a requirement. A Manufacturer merely has to have Internal Control of Production.

In Summary - Our Design services offer assistance on both low risk and high risk products;

à MDD 93/42/EEC Design Verification for Class I and IIa Devices.

à Compilation of Design Dossier to meet 93/42/EEC Annex II Clause 4. Requirements

à Review and Report of the effectiveness and compliance of all the above aspects.

Thank you for visiting this Web Site. A more detailed Company Profile is available. If you require further information on any Medical Device compliance issue, or if you have any suggestions to improve this Web Site, please feel free to e-mail Bernard J. Tremaine at:

bernardt@mdqaconsultancy.co.uk

To find out how M.D. & QA Consultancy can help you accomplish your PRODUCT APPROVAL / DESIGN CONTROL  goals, please complete the Contact Us form , and someone will get back to you a.s.a.p. to discuss, in total confidence, how we might assist you .

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Medical Device & QA Consultancy

 offers a complete Design Control service covering the following aspects;

à Implementation of Design Control systems to meet;

à ISO 9001:2000 à ISO 13485:2003 à FDA 21 CFR 820.30, including;

  · Effective Design and Development Planning including Design Reviews at appropriate Process Stages

· Establishing Hazard Evaluation and Risk Analysis requirements and defining the appropriate Stages throughout the Design Process for conduction

· Establishing the appropriate Organisational and Technical Interfaces

· Identifying all appropriate Safety, Standard, Customer< Company and Other Design Input requirements

· Reviewing and Controlling the Design Output documents

· Conducting Design Verification to give assurance that Specified Requirements have been met

· Conducting Design Validation to ensure that Customer Requirements are being met

· Controlling Design Changes effectively

· Controlling the Transfer of Design Output documents to Manufacturing (FDA 21 CFR 820 requirement)

· Ensuring that Safety Specific, Post Market Feedback and Adverse Incident Reporting data is identified and Links into the Design Process at appropriate Stages.