Medical Device Compliance Consulting: Questions to Ask Before Hiring

Medical Device Compliance Consulting: Questions to Ask Before Hiring If you are medical device manufacturer and you are now you think you are ready with medical device and wants to launch in the Market. Some time you may not have regulatory back up to do job on your own and you may think of hiring consultant. No Issues, this is what most companies do.

Steps to follow to bring to market are same for long period of time like normal documented process from design to release in the market. You may feel easier job, but do you know that regulation you have read and tried to comply successfully has changed now? These are happening every now and then based on feedback of users and medical device professionals. Regulatory bodies like US FDA and EU MDR act and change regulation in the interest of patients who are real impacted people. This is where role of consultant competency counts.

Choose consultant but do ask them following question before hiring.

1. HAVE YOU HELPED A COMPANY PASS OUR REGULATORY STANDARDS? If yes, which one US FDA, EU MDR? 2. What experience you have working with any Medical device company? which company/companies you have worked with?

3While working with such medical device company did you got an opportunity to work with similar device we are interested in launching? (like similar type, similar class) 4. HAVE YOU WORKED WITH A COMPANY IN OUR SITUATION? 5. HAVE YOU WORKED WITH OUR EQMS? 6. HAVE YOU WORKED WITH companies of similar size?

7.Doyou also have exposure of working with any such company where product lifecycle is our stage?

8. How do you rate your job as successful?

9. what is the system of your charging your clients?

10. HOW MANY SUBMISSIONS HAVE YOU WORKED ON RECENTLY? 11. WHAT OTHER SERVICES DO YOU PROVIDE? 12. Do you do all job at your organisation level or do some outsourcing also? Meaning dealing with regulatory bodies at overseas level do you use local people or do all job online.

It is important to note that consumer confidence is what is so essential to build as they are your real customers, and this comes from your success rate. In case of issues, in any past then your approach to deal with it to bring back consumer confidence.

Failure is unaffordable as it can ruin your business.

Quality has got to be core strength of your company. if youwant to truly rise above your competitors and claim your market share, proper QMS system and team in situ, is the answer.