MEDICAL DEVICE REGULATORY CONSULTANT

INTRODUCTION

A medical device is used for various medical purposes like to mitigate, prevent, diagnose, treat diseases and it achieves its purpose through physical or mechanical action. It assists patients with working on their personal satisfaction. There is always a regulatory criterion by the governments for these medical devices before the introduction of these devices in the market as there may be associated hazards. Examples of medical devices are pacemakers, medical thermometers, intraocular lenses, stents, etc.

MEDICAL DEVICE CONSULTANTS

Manufacturers of medical devices work with consultants to develop a product and bring it out in the market. Consultants are experienced professionals with years of experience in the medical sector

HOW TO CHOOSE THE RIGHT CONSULTANT FOR YOUR MEDICAL DEVICE?

If we talk about the legal perspective then I can quote the example of a country named GERMANY which has a law according to which it requires medical device consultants. No other country includes such a concept. Now the question arises how to choose the right consultant for the desired medical device, following steps should be kept in mind-

• The first step is to identify the need for having a medical device consultant. The requirements of the user of the medical device should be defined.
• The second step is to decide whether the user needs a consultancy or an individual consultant-
• The third step is to match the experience of the consultant in the relevant field with the medical device to be developed for the user
• The fourth step is to check the experience of the consultant whether he has worked with the user’s quality management software otherwise there will be an additional cost to train your consultant.
• The fifth step is to check the geographical location of the consultant.
• The sixth step is to identify and watch the total cost which will be required to pay the consultant
• The seventh step is to ask for the reference of the consultant from the previous clients.

WHAT DOES A MEDICAL DEVICE CONSULTANT DO?

 If any person is interested in the medical sector but he does not want to directly deal with the patients, then he can prefer the career of medical consultant and in that category, there comes a person who can also work as a medical device consultant.

The need for medical consultants arises because the medical devices sector is excessively regulated and the process to bring the device finally in the market is too complicated. Consultants advise them from top to bottom so that the devices are introduced in the market without getting rejected in the early process. There are various kinds of services offered by the medical consultant’s like-

a) To advise the road to regulation which depends on that particular therapeutic area

b) To put the product in front of the related stakeholders for the best opinion

c) To analyze the clinical trial data

d) Optimization of design and development of medical devices

WAYS TO CHOOSE THE RIGHT CONSULTANT FOR YOUR ORGANIZATION

• Evaluation of the pricing model before selecting the consulting organization.
• Choose an organization that focuses on quality management system and they have diverse talent sources.
• There should be some innovative solution by the Organization so that they can manufacture quality devices.
• Remember to check the past experiences of the consulting Organization like their expertise in the selection of materials for device development.
• Medical device development organization should be confirming ISO certification for quality management
• The development partner should have the ability to work on further improvements in the design and development of devices.
• The Organization should have the capability of verifying that the device developed meets the need and purpose for which it was identified.

CONCLUSION

It is critical to choose the right consultant for your organization because it increases the budget of the manufacturer but it also helps the manufacturer to avoid the unnecessary risk of developing a faulty device. One must be careful and wise in choosing the right consultant which may result in a reward and win-win situation for both the consultant and the manufacturer.

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