Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Premarket notification is an intricate process for medical device manufacturers to navigate. Levels of risk, assurances of safety and effectiveness, device type, intended use, and a whole manner of other factors can shift your submission from PMA to De Novo to 510(k) in the blink of an eye.
Of all the dynamic aspects of life science product development, risk management is one of the most important. From an organizational standpoint, controlling risks associated with your products protects your business interests; likewise, it ensures higher levels of care and safety for patients and users. When done in an iterative fashion from the start of development, thorough risk control can have significant impacts on your products, services, and organization.
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After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical data quality and integrity, as well as to protect human subjects’ well-being and safety. As a way of keeping domestic and international premarket medical device submissions consistent for regulatory review, the new acceptance criteria take aim at very particular issues in the compliance process for clinical investigations.
Managing the risks of your life science product can be a complex task. Some risks must be assumed, while others need to be controlled, transferred, monitored, or designed out of the product entirely. Implementing risk controls to reduce and manage the impact of associated risks, as well as their probability of occurrence, is the most common approach manufacturers leverage in their design and development efforts.
For many life science organizations, long-term growth is a primary goal. Whether focused on greater stability, increased revenues, or more diverse product portfolios, the need for expansion can drive how a company thinks and operates. However, pushing to expand your business is not without its difficulties.
FDA was very busy in February 2019. In our latest edition of our FDA Pulse Check series, we’ve highlighted some of the month’s key stories worth catching up on.
As your life science organization advances and begins to expand its teams and portfolios, opportunities for productive, long-term growth present themselves. However, these opportunities aren’t always realized to their fullest extent or are missed out on entirely. If you’re struggling to grow your life science company, what could be slowing you down? To answer this question, there are four key areas you should take care of: process maturity, people, planning, and product portfolio management.
The medical device industry is in a state of immense change. Powered by technology, there are now incredible opportunities to improve patient outcomes, offer new and dynamic treatments, and help your organization thrive as a result. However, this technological change brings with it a number of new and evolving risk factors specific to our modern landscape.
Life science product development can sometimes be a niche enterprise, and for good reason—certain populations and conditions require specific solutions and treatments. Providing these can be a boon to both patient outcomes and your organization’s bottom line, as well as progressing that particular field of treatment.