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OTHER MEDICAL DEVICE SERVICES OFFERED
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Other PRODUCTS SERVICES and INFORMATION Distance Strategy for Class I Devices Quality Management FDA 21 CFR 820 / ISO 13485 / EN 46000
UK Competent Authority - Medical Device Agency (MDA) Notified Bodies under Directive 93/42/EEC Download a copy of the Medical Device Directive 93/42/EEC now Summary of the steps to comply with the Medical Device Directive |
THE OPTIONS
OPTION 1:
1 - Review your current ISO 9000:1994 Quality Manual and provide you with a written report, detailing the deficiencies against the ISO 9001:2000 Standard, for example: Mapping your Processes, Identifying Process Inputs and Outputs and Identifying relevant Performance Indicators
For medical device manufacturers, let us assist you to incorporate ISO 13485:2003 into your Comapny........
1.1 - Give you advice to help you to implement the changes into your Level 2 documentation.
1.2 - e-mail support for 90 Days after the date of (1) above.
Fee: GBP 275 / USD $ 430
OPTION 2:
2 - Same as (1) above, but with support extending to 180 days.
Fee: GBP 395 / USD $ 615
OPTION 3:
3 - Name your own Level of support......let us know your exact requirements and a package can be customized to exactly meet your needs...
Fee: A Quotation will be generated, based on your requirements..... All enquiries will be treated in the strictest of Confidence and we would be pleased to sign your Company's Non-disclosure Agreement.... To CONTACT US please; Please Fill Out This Form In Total Confidence: OR E-mail: mailto:bernardt@mdqaconsultancy.co.uk OR E-mail: regaffairs@mdqa.co.uk
Tel: + 44 7973 708 957 Fax: + 44 161 903 9787
AUTHORIZED REPRESENTATIVE SERVICE PROVISION Thank you for considering Medical Device & QA Consultancy to help you meet your Regulatory Responsibilities
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