FDA Announces Innovation Challenges to Find New Methods of Device Sterilization

By MedTech Intelligence Staff

The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.

IDMP: Back on Track and Bearing Down with New Urgency—What’s Next?

By Siniša Belina, AMPLEXOR

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.

FDA Approves Abbott’s Fourth-Gen MitraClip

By MedTech Intelligence Staff

The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.

Featured Quote

The challenge manufacturers have with UDI implementation has more to do with understanding from a regulatory perspective what is happening.

— Jay Crowley, USDM Life Sciences

NEXT WEEK:

Technical Writing Workshop Focuses
on Key Elements for Lifescience Companies

By MedTech Intelligence Staff

This two-part virtual workshop will guide participants through the process of how to write effective documents.

With Concern over Adverse Events, How Can We Improve Patient Safety?

By MedTech Intelligence Staff

Medtech manufacturers must continue to embrace collaboration and transparency.

• Medical Device Audits, Certification & Verification
• Quality & Regulatory Market Access Solutions
  sponsored by UL
• Medical Device Component
  sponsored by 3M
• Medical Recall

How to Choose the Right Material for Your Medical Device

For many medical device designs, the best resin or combination of resins for a product depends on the device’s requirements. This blog focuses on three questions (1. What unmet need is this device satisfying? 2. What performance demands does the design place on the material? 3. What is the target cost per part?). These will guide OEMs and their contract manufacturing partners toward optimal material choices for their medical device product.

Click to read.

Science of Skin: Skin Through the Ages - White Paper

Skin is the boundary between who we are as we present ourselves to the world while acting as the barrier to the insults that we experience in our day-to-day existence. Skin is the largest organ in the body and as such it is critical to the maintenance of our bodies. If we suffer damage to our skin, we can suffer a loss of function.

Access White Paper here