Cup of Joe #49 – Do You Need A Consultant?
With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.
It's not an easy process to bring a medical device to market. Medical device companies operate in a complex global regulatory environment with continually changing standards. There are many obstacles that must be overcome. Many MedDev companies are struggling to cope with ISO 13485:2016, FDA or CE mark submission, or post-market surveillance.
Even though it doesn’t always appeal to company leaders, but if the MedDev company doesn’t maintain perfect quality control or does not achieve the set goals, they should consider hiring a consultant.
Expert guidance and planning for the development and implementation of an ISO 13485 compliant QMS, will considerably reduce the time and expense involved.
You might want to hire a consultant to help you identify a problem, or to clarify the implementation of the standard like ISO 13485:2016 or 14971:2019. Achieving any of these standards for management systems involves a range of disciplines and stages at which consultants can provide guidance and support. They can perform various roles such as advisory, implementation, management, or internal auditing. Every QMS consultant or consulting agency will customize their services to your ISO 13485 needs.
Have in mind that you'll get approval faster when you have a consultant that understands what you need and how to navigate you through it.
Let’s summarize a couple of benefits to hire a consultant:
- Your QMS development and implementation time will be reduced
- It’s a faster way to your ISO 13486:2016 certification
- Your QMS processes will have improved effectiveness and efficiency
- Based on your product’s classification you’ll have a fulfillment of all legal and regulatory requirements
- Your medical device company will have a satisfaction of development of a continual improvement
You might think that hiring a consultant might be expensive, but this is a common misconception. Hiring a consultant is an investment in the success of the project. The cost of hiring a consultant and the time he/she will take to implement your quality management system will definitely pay off in the long run
Don’t forget, your success is their success.
