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...
by Waltteri Sorvisto | May 7, 2026 | Medical Device Services
Medical device development often begins with a strong technical idea. For startups, that early momentum is important. A prototype, a clinical need, or a promising technology can create the energy needed to move a product forward. But in medical device development,...
by Waltteri Sorvisto | Apr 29, 2026 | Product & Compliance
Medical device software is often discussed primarily as a development challenge. The focus tends to be on functionality, performance, architecture, and how the final product will behave in use. All of that matters. But in regulated environments, software development...
by Waltteri Sorvisto | Apr 23, 2026 | IPR
In product development, intellectual property is often discussed relatively late. The conversation tends to begin when an invention is ready to be protected, a filing strategy is taking shape, or external investors start asking how the company plans to defend its...
