Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
When outsourcing these key functions, asking the right questions will help minimize the risk.
How manufacturers can better understand their customers in a rapidly changing provider environment.
Look for the good, the bad, and the ugly, but above all, look for anything that affects patient safety.
All employees who handle patient information must be appropriately trained to HIPAA.
Although many device companies are seeking cost savings when seeking sourcing products or components manufactured in Asia, quality should not be compromised. Intense due diligence is important.
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.