Medical Device Management Ltd.

57 The Lakes
Lower Chapel Hill
Braintree
Essex
CM7 3RU

Tel +44 (0)1376 342303
Fax +44 (0)1376 342304
E-mail admin@medicaldevicemanagement.com



You are here: Home > Services > International Regulatory Affairs
International Regulatory Affairs
..Specialists to the Medical Device Industry


When experience counts

The team at Medical Device Management fully understands the importance of sound regulatory advice and support to its clients.

Whether you are a major healthcare multinational, a start up or even a virtual company we have the skills and regulatory expertise to help you to achieve your goals efficiently and cost effectively.

Regulatory Strategy

No medical device company would consider trading without a formal business plan and marketing strategy in place and yet many companies seem to have little or no regulatory strategy at all.

A proactive approach to regulatory issues helps to ensure that delays are avoided and that products get to market on time.

Medical Device Management specialises in helping its clients to develop a sound Regulatory Strategy and then integrating it into the business plan to ensure faster access to the all important revenue stream, building profitability and paving the way to further success.

Ongoing regulatory support packages are available specifically tailored to meet requirements of individual clients and offering as much - or as little support as is needed, at prices that reflect
a longer term relationship.

Why MDM?

Honest
Medical Device Management will supply honest advice, based on experience, to enable you to develop a realistic and achievable regulatory strategy.

Professional
From the senior management team through to the most junior regulatory consultant, all of the team at MDM participate regularly in training programmes with organisations such as BSI, the FDA and Health Canada, to ensure that the advice given to its clients is both current and accurate.

Cost Effective
MDM do not work on an open ended hourly rate basis. Instead clients receive a firm quote for a specific project with agreed delivery dates and achievement milestones.

Experienced
The company is staffed only by experienced medical device industry professionals who have a thorough understanding of the processes involved in the development, registration and marketing of medical devices.

Customer Satisfaction
Medical Device Managements has gained the reputation of going the extra mile and constantly striving to ensure that clients expectations are not only met, but exceeded. MDM is the company that delivers.

Thinking globally

With clients throughout Europe the Americas and the Pacific Rim, MDM is able to take a global perspective on regulatory issues.

As well as being able to offer support with FDA 510(K) applications via its US office MDM is also able to offer European representation for its clients from outside of the European Community.

MDM has the experience and cross functional perspective to deliver cost effective regulatory solutions for its clients around the world.


BSI registered
All content © Medical Device Management Ltd. | Website by ICO3