by Waltteri Sorvisto | Jun 18, 2026 | General
As Sankt Hans approaches, the MDS blog will be taking a short summer break. Over the past months, we have covered a wide range of topics across quality management, regulatory affairs, clinical activities, FDA strategy, IPR, software development, and MDR readiness....
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 | Jun 4, 2026 | IPR
In medical device development, intellectual property and regulatory strategy are often treated as separate workstreams. Patent matters may be handled by IP specialists, while regulatory planning is managed by QA/RA teams, clinical experts, or product development...
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...
