There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
The first steps into clinically practical tissue engineering are through in-situ tissue engineering of bone.
After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.
Understanding the value of the VA and DoD device markets and how to best optimize access and revenue.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
By simplifying labeling compliance, companies can focus on better serving current and new markets.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
The company is dedicating more funds to research, development and innovative projects.