qualimedd.com

Qualimedd

An International Quality Systems and EU Directives Implementation Service. For the Medical Devices and In Vitro Diagnostics Industries. For all Class I, Class IIa, IIb, Class III Devices and IVD's. We offer a professional service specifically designed to assist both start up and established companies and have worked with organisations ranging from one man companies to corporations employing thousands worldwide. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

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Qualimedd | qualimedd.com Reviews

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An International Quality Systems and EU Directives Implementation Service. For the Medical Devices and In Vitro Diagnostics Industries. For all Class I, Class IIa, IIb, Class III Devices and IVD's. We offer a professional service specifically designed to assist both start up and established companies and have worked with organisations ranging from one man companies to corporations employing thousands worldwide. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

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Qualimedd | qualimedd.com Reviews

https://qualimedd.com

An International Quality Systems and EU Directives Implementation Service. For the Medical Devices and In Vitro Diagnostics Industries. For all Class I, Class IIa, IIb, Class III Devices and IVD's. We offer a professional service specifically designed to assist both start up and established companies and have worked with organisations ranging from one man companies to corporations employing thousands worldwide. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

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qualimedd.com

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Qualimedd

http://www.qualimedd.com/EU_new_approach.htm

Applicable European Union New Approach Directives. CE Marking Directive 93/68/EEC. Active Implantable Medical Devices Directive 90/385/EEC. Medical Devices Directive 93/42/EEC. In Vitro Diagnostics Medical Devices Directive 98/79/EC. Electromagnetic Compatibility Directive 2004/108/EC. Low Voltage Equipment 2006/95/EC. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

2

Qualimedd

http://www.qualimedd.com/index.htm

An International Quality Systems and EU Directives Implementation Service. For the Medical Devices and In Vitro Diagnostics Industries. For all Class I, Class IIa, IIb, Class III Devices and IVD's. We offer a professional service specifically designed to assist both start up and established companies and have worked with organisations ranging from one man companies to corporations employing thousands worldwide. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

3

Qualimedd

http://www.qualimedd.com/services.htm

Programmes are individually tailored for each client with the emphasis being on ensuring that activities comply with the required International Standards and Directives. Although a full programme is offered, clients can use our services as little or as much as desired throughout the run-up to product or company compliance and our team of experienced and qualified consultants are available to assist at all stages. Product Development and Planning. Part Time Quality Management. Quality and Audit Training.

4

Qualimedd

http://www.qualimedd.com/about_us.htm

JIM MACKENZIE MSc., MCQI CQP, MBCS CITP- Managing Director. Jim Mackenzie MSc., MCQI CQP, MBCS CITP, the principal of QualiMedd, has over thirty five years experience in the medical and diagnostics industries and has developed an in-depth knowledge of medical devices and their regulatory requirements with several major corporations both at home and abroad. Jim is a member of the Chartered Quality Institute, the American Society for Quality , RAPS, the Validation Institute and The British Computer Society...

5

Qualimedd

http://www.qualimedd.com/issues_to_consider.htm

Have you Considered the Following? Whether you are a developer and manufacturer or a distributor of Medical Devices or In Vitro Diagnostics you need to keep abreast of the myriad legislative measures which affect the industries. Do you need ISO 9001 and ISO 13485 registration? How do you apply EU Harmonised Standards? How do the various Medical Devices Directives affect you? Do you need the CE mark on your products? Is involvement with a Notified Body required? How do you control Product Development?

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An International Quality Systems and EU Directives Implementation Service. For the Medical Devices and In Vitro Diagnostics Industries. For all Class I, Class IIa, IIb, Class III Devices and IVD's. We offer a professional service specifically designed to assist both start up and established companies and have worked with organisations ranging from one man companies to corporations employing thousands worldwide. Last Updated Oct. 2008. Web Design by TEAMSTRONG.

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