Are you paying exorbitantly for your Quality and Regulatory consultants

I was talking with my CEO one day and he expressed concern regarding the cost our company was incurring on Quality and Regulatory consultants and notified bodies. We are a small Orthopaedic firm which designs and distributes implant systems and instrument for Trauma applications. We need to follow and maintain compliance with all the regulations in the markets where we have sales. As I come from a product development background, I have little understanding of the typical cost associated with hiring QA/RA consultants. It occurred to me to apply my past consulting experience where I was working with one of the large engineering outsourcing company.  Immediately,  one name came to mind. At that point, I reached out to Kuldeep Tyagi. To my pleasant surprise, I found that Kuldeep is running his own consulting company, Saraca Solutions.

I reconnected with Kuldeep and discussed with him the pains that our CEO expressed to me. He was on top of the regulation changes in Europe and the US. He explained to me that the high demand for QA/RA consultants was drivingthe high cost. He offered towork on a proposal and come back to us within a week. We were looking for someone who could take on 100% responsibility for our Quality and Regulatory needs as we have no full time staff for these two functions.

The immediate need was to coordinate our ISO 13485 audit. We are a small company and our notified body required that we submit to a 2 day audit. Saraca helped to negotiate with the notified body and reduced the audit to 1.5 days with a subsequent1 day surveillance audit the following year. This feat was remarkable as we previously always accepted the notified body’s schedule without much negotiation.

We completed our ISO 13485 audit with the least number of NCs ever.  The Saraca Team impressed the auditor with their knowledge of ISO regulations and our systems. Subsequently, we have improved our QMS with enhanced supplier controls, regular Risk analysis and strict adherence to the CER requirements.

Saraca has owned the QA/RA function of our company for the past 2.5 years, with very minimal support from us. The interesting part is that they are doing it almost 100% remotely from India with approximately 2-3 weeks/yearof onsite visits for audits.

We have reduced our QA/RA cost by 50%,during the past two years, and have found a partner who fully ownsour QA/RA function allowing us to focus on our R&D efforts. 

About the author:Saaransh Jain is Head of R&D and Engineering in Toby Orthoapedics with extensive experience in Orthoapedicimplants and instruments. He has specialized in product development, operations, design transfer, design for manufacturability, special process and cleaning validation. Mr. Jain also possesses experience in International supply chain management especially in Germany, Turkey and India.

Are you paying exorbitantly for your Quality and Regulatory consultants