There are numerous startups with a great concept but no QA/RA experience. Studying regulatory guidelines can be time-consuming and often not rewarding. Small mishaps at the beginning of the product development can later cause major non-conformances. But how to choose the right advisor for your medical device?
Choosing a Medical Device Consultant
First of all, a medical device consultant is not an official title. Quality assurance or Regulatory affairs consultant with specialization in medical devices is typically the preferred name of the job position. Diving deeper into the field of medical devices, you need to find a consultant that will fit the needs of your specific project. It is important to consider, whether your medical device needs to adhere to ISO 13485. This regulation makes sure that medical devices meet safety standards and applicability demands. EU MDR, ISO 9001:2015, or FDA 21 CFR Part 11 are some of the other regulatory necessities you might need help with, based on the nature of your product.
Proper specialization is important, but it doesn’t guarantee that the cooperation will work out. Time-zone, language, and availability can become crucial details when it comes to smoothly running processes. It is also important to consider the pros and cons of hiring a remote consultant. Finally, their experience and previous clients can help you figure out whether they are a good fit for the size of your company.
Now that you can imagine your perfect consultant, how do you find one? More importantly, how can you be sure that they will be able to deliver the guidance they are promising?
We created a list of top medical device consulting firms that provide a high-quality service in their respective specializations.
Top Medical Device Consulting Firms
Country: Sweden, Denmark
Country: United Kingdom
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