PDD has completed its planned transition to the latest version of this rigorous international quality assurance standard for medical devices, building on the success of earlier transitions and successful audits to the FDA 21CFR Part 820 in 2015.
It’s a considerable achievement for PDD, representing a great collective team effort over several months. It puts PDD in a strong position to support the needs of similarly-certified clients, future-proofs our current work and allows us to advise clients which haven’t yet transitioned themselves.
ISO13485, which was originally based on ISO9001:1994, marks the most significant change for R&D-based companies since the introduction of the earlier 2003 version. It includes many of the now widely-accepted best practices of cGMP (current Good Manufacture Practice) and developments contained within the US FDA 21 CFR Part 820.
The greatest area of change in ISO13485:2016 – perhaps prompted by the rise of collaboration in the medical devices field – is within the selection and management of subcontractors and suppliers. There is now increased motivation for medical device manufacturers to use companies with equivalent ISO13485:2016 certification, or be obliged to additional levels of management control otherwise. However, the accompanying cost burden of the latter diminishes the value of external appointments.
Having achieved this transition to the highest standards of international quality assurance, our greatest challenge is presented by the context of our quality; that we continue to ensure appropriate human-centred innovation; with viable creativity and feasible invention, alongside the quality and regulatory compliance.
PDD has extensive knowledge, a large toolkit of methodologies and a team skilled at gaining insight and translating this into creative and ingenious solutions. The unending challenge is to break new ground and yet maintain rationale and predictable ‘right-first-time’ delivery that can also be verified and validated.
PDD gained its ISO13485 certification in 2003. Developing it for 14 years has meant extensive application experience and continuous refinement. We can now offer our clients the advantage and efficiency of aligning current projects to conform to the latest standard before the transition deadline looming in early 2019.