Companies within the life sciences industry should rethink how they manage their data and documents.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Regardless of the reason for disposing of a medical device or other electronic equipment, the product must be destroyed in a manner in which it can never be reused or identified as coming from your organization. In addition, the resulting materials from the destruction process be disposed of in an environmentally appropriate and regulatory compliant manner.
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
During product development, collaboration between software, hardware and quality teams must be tracked and seamless to meet the increasing pace of market demand.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
While connected capabilities and wireless technology certainly lead to greater patient care, they also expose devices to greater cybersecurity risks.
This year’s virtual event features experts from medical device companies, hospitals and government organizations.
Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators. But many firms in the medtech sector are not maximizing the opportunity to deliver regulated product information digitally.