Management Representative

One of the key requirements is for top management of a medical device company to appoint a ‘management representative’ with executive responsibility to oversee the quality system practiced in the medical device company. Of course, this management representative must be qualified enough with years of quality system experience.

Often time, when the officials from a regulatory body show up, this management representative will have to interact with them.

Basically some of the executive responsibility of this management representative is to

a)  Ensuring quality system requirements such as 21 CFR 820 and ISO 13485 etc in the company are effectively established and effectively maintained accordingly.

b) Reporting on the performance of the quality system to management with executive responsibility for review to ensure it is in compliance with all related quality system related to the company. For example, if the company is selling product to Australia, the company ought to be in compliance with quality system stipulated by Australian Government Therapeutic Goods Administration (TGA).

c) Management and management representative shall review the suitability and effectiveness of the quality system at defined intervals like twice a year. All the activity must be made into a procedure for example with quality policy and objectives.

The dates and results of the quality system reviews shall be documented with detail of what had been discussed.

Another thing, it is advisable for the top management to write a letter of appointment to formalize the appointment. The CEO or quality director should sign the letter of appointment. Below is the exact wording from FDA website.

820.20(3)	Executive management shall appoint a Management representative (MR).with executive responsibility.
820.20(3)(i)	He or She shall have authority over and responsibility for:a) Ensuring quality system requirements are effectively established and effectively maintained accordingly.
820.20(b)(ii)	b) Reporting on the performance of the quality system to management with executive responsibility for review

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.