Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise

Background

Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted complete validation within a few weeks, saving significant engineering hours and reducing potential product release delays.

Challenges
The customer realized the importance of CSV. However, no one on their team was willing to take it on. Many on the team viewed CSV as a distraction from other, more meaningful and fulfilling work. The in-house IT team couldn’t take on CSV because they lacked the depth of Solidworks knowledge necessary, as well as an engineering background. Still, the FDA requires CSV. If ever audited, they would receive a warning letter and be required to perform CSV after the fact, leading to delays in product release. The company likewise wanted other advantages of CSV, including effective change control and continuous improvement. However, due to the man hours associated with CSV, the company felt there was no real return on the investment.

Solution
SPK and Associates delivered all FDA-required CSV documentation in a month, compared to several months the customer spent trying to do it on their own. We achieved this by leveraging templates we’ve developed over decades of experience. Our experience working with SolidWorks, and specialization in medical device-focused engineering, empowers us to take templates and customize them for individual customer needs. We continue to work closely with this customer, holding their CSV so when they need to re-CSV, we can make quick changes rather than starting all over again.