ISO 9001:2000  / ISO 13485:2003

If you are Implementing the old version of ISO 9001/2/3:1994 and want to move to the New version, let us help you make the Transition in a way that will cause you least pain.... 

 

OTHER

MEDICAL

DEVICE 

SERVICES

OFFERED

 

Medical  Device & QA ConsultancyOperating room caption

Other PRODUCTS SERVICES and INFORMATION

Authorized Representative

Class I Self Certification

Conformance Routes

Design Control

Design Dossier

Distance Strategy for Class I Devices

FDA 510(k)

Frequently Asked Questions

Hazard Evaluation

ISO 9001:2000

Medical Device Safety

Own Brand Labeling

Post Sales Issues

Quality Management FDA 21 CFR 820 / ISO 13485 / EN 46000

Regulatory Affairs

Retained Consultancy

Review of Safety

Technical File

Company Profile

Home Page

Track Record

e-mail us


LINKS TO OTHER MEDICAL DEVICE SITES

List of Competent Authorities

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

Medical Device & QA Consultancy's HOME PAGE

 

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