purple background

Medical Devices

White Paper

Beyond the CE Mark: How to Collect Clinical Evidence to Ensure EU MDR Compliance

  • PDF (328.07 KB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

White Paper

Navigating the Pre-Market EU MDR Journey

  • PDF (364.08 KB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

White Paper

China: NMPA and the New Medical Device Regulations

  • PDF (1.09 MB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

Webinar

Collecting Clinical Evidence In The Post-Market Era

  • External Link

Get Your Copy Now When You Need to Advance Your Final Medical Device to the EU Market, It Takes Avania...

Webinar

Collecting and Evaluating Clinical Evidence In The Pre-Market Phase

  • External Link

Get Your Copy Now When You Need to Advance Your Final Medical Device to the EU Market, It Takes Avania....

Fact Sheet

Medical Writing Fact Sheet

  • PDF (771.65 KB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

Fact Sheet

Analytics Fact Sheet

  • PDF (3.93 MB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

Blog

EU Medical Device Regulation 2017/745 – First Formal Amendment, Delaying Date of Application

  • May 4, 2020

On 24 April 2020, the first formal amendment to the EU Medical Device Regulation (MDR) was published in the Official...

Fact Sheet

Clinical Evaluation Reports

  • PDF (729.43 KB)

Get Your Copy Now Name(Required) First Name Last Name Company name(Required)Email(Required) Consent(Required) By checking here, you agree for the information...

Blog

Post-market surveillance under a “522 order” — why, what, and how?

  • April 9, 2020

Company X has gained 510(k) clearance for their new heart valve and was notified by the Food and Drug Administration...