Medical  Device  &  QA  Consultancy

RETAINED CONSULTANCY PARTNERSHIP

Relax with Total Peace of Mind in the knowledge that answers to all your Regulatory and Quality Management System requirements are only a telephone call (or   e-mail or fax ) away.....

Medical Device & QA Consultancy offers the above within a Partnership approach and can provide for:

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²  a timely response with an effective solution to your Medical Device or Quality Management System related queries&

²  periodic meetings to enable you to Plan ahead effectively and help with the Continuous improvement of your Quality Management System

²  Two, Four, Six or  Eight visits per year can be pre- arranged, to suit your Quality Management System, Regulatory or Business Improvement objectives, including Staff Training, Internal Auditor Training and Supplier (2nd party) Evaluations/Audits.

²  Using Medical Device & QA Consultancy to complement your own Internal Audit function, will enable you to benefit from the independence of a  third party Auditing of your Quality Management System. We can bring to an Audit our vast experience of auditing a wide variety and range of Medical Device Manufacturers, which will enable your Company to benefit from Industry Best Practice .

²  Additional Project work that that could be undertaken, at a reduced cost, could be:

 · Integrating any or all of the following into one business system;

- ISO 9001:2000

- ISO 13485:2003

- FDA 21 CFR 820 QSR

- MDD 93/42/EEC

- IVD 98/73/EC

 · New Product Development and Design Control

²  a known fixed annual cost of a major part of your Cost of Quality calculation  

²  benefiting from Medical Device & QA Consultancy's vast experience in Auditing Companies like yours, for their compliance with the Medical Device Directive (93/42/EEC), on behalf of UK Notified Bodies, ensures that you will always be abreast of Industry Best Practice ,

²  For North American Companies, in addition to the On Site Visit package outlined above, a Tailor Made Package can be arranged, consisting entirely of a Distance Strategy, with informal On Site visits being arranged, when we are in your area, to minimize your costs.

 ² A 12.5% reduction on standard fees would apply to this Project. The same fee reduction would be applied to any additional Project work, that we might undertake together, as part of our Partnership agreement.

² Use of Medical Device & QA Consultancy to Evaluate and Control your Suppliers & Subcontractors

For further information or to request a quotation, please fill out the Enquiry Form at;

 http://www.mdqaconsultancy.co.uk/feedback.html OR Telephone + 44 161 980 4310       Fax +44 161 903 9787