CE Mark for Medical Devices Sold in Europe
J. H. MACKENZIE
100023.3435 at COMPUSERVE.COM
Fri Nov 3 13:05:59 EST 1995
In reply to messages regarding CE Mark for Medical Devices Sold in Europe:
1. Guidance documents on the medical device directive and CE marking are
available but run into 100 + pages and are not suitable for e-mail.
2. Diagnostics companies do not have to comply with the MDD but will have to
comply with the 'in-vitro diagnostics medical device directive' when it becomes
law. (A draft has been recently published.)
3. My company specialise in assisting companies world wide with compliance to
such directives and to ISO 9000. Details are as follows:
Whether you are a designer and manufacturer or a distributor of medical devices
you need to keep abreast of the myriad of legislative measures which affect the
Do you need ISO 9000 registration? How have the Standards changed?
Is TickIT registration required for your software?
What about new FDA GMP Regulations?
How will the EU Directives Affect you?
Medical Devices Directive?
In-vitro Diagnostics Directive?
Do you need the CE mark on your products?
Are your instruments affected by EMC and low voltage Directives?
If you have concerns about any or all of the above then M C S's QualiMedd
service is designed to help you.
M C S
M C S is an independent U K based consultancy established early in 1990 and
working within the areas of quality improvement specialising in Clinical
Instrumentation, In-Vitro Diagnostics, Healthcare, Bio-Technology and Medical
Devices in both manufacturing and service companies.
QualiMedd is a specialist service specifically designed to assist with quality
and regulatory issues within the healthcare industry.
Experienced in the requirements of both manufacturers and customers, M C S
offers technical guidance to clients in all areas from the explanation of
requirements through preparation of detailed plans for regulatory systems, to
assisting with the documentation and implementation of processes and procedures,
culminating in final registration of systems and products to the required
standards. Throughout the process the emphasis is firmly on quality and clients
are kept closely informed and involved at each stage.
Current M C S clients include companies ranging from a staff of under ten to
companies employing several thousand Worldwide.
M C S is currently working in the following industries:
Medical / Analytical Equipment and In-vitro Diagnostics, Information Technology,
Bio Technology, Medical Devices and Genetic Engineering.
Programmes are individually tailored for each client with the emphasis being on
ensuring that activities comply with International Standards.
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 registration and
our team of experienced and qualified consultants are available to assist at all
Jim Mackenzie, the principal of M C S , has over twenty years experience in the
health care industry and has developed an in-depth knowledge of medical and
diagnostic regulations and instrumentation with several major corporations both
at home and abroad.
Jim's career started as an engineer with Technicon Instruments where he
subsequently held several technical and management posts, both at home and
overseas, before moving into senior management with American Monitor Corporation
Jim was also Corporate Instrumentation Manager for Serono Diagnostics before
starting out as a consultant by setting up MCS early in 1990.
Being a qualified bio-medical engineer and both a Quality Systems lead auditor
and a TickIT software lead auditor, Jim Mackenzie is ideally placed to provide
an unrivalled support service to all sectors of the healthcare industry, whether
they be designers and manufacturers or end users.
Jim is a long standing member of The Association For Services Management, a
member of the Institute of Quality Assurance and is a recognised authority on
all aspects of customer service and Quality Management within high technology
For further details on how the M C S QualiMedd service can help your products
and your business please complete the attached card or contact us directly:
MACKENZIE CONSULTING SERVICES
Telephone: (44) - (0)1628 - 782537
Facsimile: (44) - (0)1628 - 782537
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