by Waltteri Sorvisto | Aug 21, 2026 | Consulting, Medical Device Services
Strong quality and regulatory teams are fundamental to medical device companies. They understand the product, the organisation, its history, and the practical realities behind the quality management system. They are often the people connecting product development,...
by Waltteri Sorvisto | Aug 6, 2026 | Medical Device Services, Quality Management
As the summer holiday season begins to draw to a close, teams across the medical device industry are gradually returning to their usual routines. At MDS, the summer months have remained active. While project schedules may look different during the holiday period,...
by Waltteri Sorvisto | Jun 11, 2026 | FDA, Quality Management
For European medical device companies, entering the US market often requires adjusting to a different regulatory system. The FDA pathway has its own terminology, submission routes, inspection expectations, and post-market requirements. Even companies with mature EU...
by Waltteri Sorvisto | May 28, 2026 | Medical Device Services
PRRCs and QA/RA teams carry a wide set of responsibilities. Technical documentation, clinical evidence, post-market surveillance, vigilance, supplier control, quality systems, audit readiness, regulatory strategy, and authority communication all need attention. In...
by Waltteri Sorvisto | May 21, 2026 | Medical Device Services, Quality Management
Internal audits are sometimes treated as a routine requirement. Something that needs to be scheduled, completed, documented, and closed before the next external audit or certification milestone. In practice, they can be much more valuable than that. A well-conducted...
by Waltteri Sorvisto | May 13, 2026 | Medical Device Services
In the first part of this series, we looked at the early decisions that shape a medical device project: intended use, requirements, risk management, regulatory strategy, and clear responsibilities. Once the direction is set, the next challenge is building the...
