Empower product development by leveraging design thinking for design controls Commonly viewed as separate stages within the product development cycle, design thinking and design controls have a significant overlap, which means that key design thinking tools can feed into, and take feedback from, design control methods.
How can an agile approach benefit medical device development? There’s a common assumption that agile working just means speeding things up. And as medical device development is a lengthy and compliance-heavy process, agile might not seem like an obvious fit. But it’s a misconception that agile practices and medical device development are incompatible. In fact, […]
New Whitepaper Advances A Structured Approach To Medical Device Development Medical device development is a complicated and heavily-regulated industry which carries an inherent possibility of costly, and potentially life-threatening, errors in data, if that data is not recorded using a consistent and systematic approach. And that’s where a structured approach can add another layer of […]
Medical Device Risk Management Tools: Assessing Your Options Medical device manufacturing is highly regulated, with a ceaseless requirement to minimize and mitigate risk in design, development, and manufacturing. Software solutions can help to ensure consistency and objectivity in the creation, auditing, and monitoring of vital risk management processes. But as a medical device manufacturer, how […]
Zero Margin For Error: Managing Change In Medtech The medical device industry is heavily regulated for a reason. Without a rationale, checks and balances, evidence, and assurance of safety, change management in medtech could become potentially life-threatening.
Reusability: Reliable Acceleration Of Medical Device Development The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market.