To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
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.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Are remote laparoscopic and open surgical procedures on the horizon?
The hot issues are related to compliance, EU MDR and recalls.
Aging is not for the faint of heart.
The requirements an adhesive must fulfill to hold your device to it safely provide a myriad of opportunities to fail.
Adhesives are ubiquitous. With virtually limitless applications, the retail stick-to skin market is a good choice for companies looking to expand their product offerings.
Most devices are still developed in a moment of need and not in advance like adult devices.