EU MDR Workshop Series -

MedTech Intelligence

Volume 11 Issue No. 07



Sloan Gaon, PulsePointVoice Technology Is Here and Will Change Healthcare

By Sloan Gaon, PulsePoint

The explosion of this technology is changing patient interaction with physicians, hospitals, and the entire healthcare landscape in general.



Featured Articles

EthiconAnother Cash Deal:
J&J’s Ethicon to Acquire Auris Health for $3.4 Billion

By MedTech Intelligence Staff

The deal will help J&J speed up its entry into the robotics market.

FDAFDA Issues Guidance on 510(k) Exemption of Certain Low-Risk Devices

By MedTech Intelligence Staff

The agency’s intent is to decrease regulatory burden while promoting patient access to products.

EU MDR: Breathe Easy on Clinical Evaluation ReportsEU MDR: Breathe Easy on Clinical Evaluation Reports

By Scott Edwards, Maetrics

The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.

Giselle C. Matlis, Axendia, Inc.Children Are Not Small Adults
Kids Need Pediatric Devices

By Giselle C. Matlis, Axendia, Inc.

Most devices are still developed in a moment of need and not in advance like adult devices.

Edwards Lifesciences Corp.Edwards Lifesciences Acquiring CAS Medical Systems for $100 Million
in Cash

By MedTech Intelligence Staff

The deal will help strengthen the Edwards portfolio of smart monitoring technologies.

FDA Encourages Innovation and SafetyFDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul

By Amy Scanlin,
EAS Consulting Group, LLC

The agency is increasing its focus on risk reduction and increased oversight while also promoting innovation.

Sponsored Content

Accumold5 Things Everyone
Needs to Know About
Micro Molding

With the pressure on design engineers to deliver smaller, lighter, and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like - What is micro molding? How is it different from standard molding? – are commonly asked by engineers. This whitepaper will explore the answers to these and other pertinent questions.

3M - Learn the science of sticking to skin

Contact Marc Spector about MTI advertising programs.

Advanced CAPA & Root Cause Analysis Conference - March 26-27, 2019 - Washington, DC

MedTech Import/Export Workshop - April 15 - 16, 2019 - Washington, DC

Medical Device Recalls Conference - May 21-22, 2019 - Washington, DC

Resource Centers

Resource Centers are single topic focused micro-sites within that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Cybersecurity Conference - June 4 - 5, 2019 - Boston, MA

Upcoming Events & Webinars

March 2019March 5-6, 2019 - EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact
Washington, DC

March 2019March 6-7, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

March 2019March 26-27, 2019 - Advanced CAPA & Root Cause Analysis
Washington, DC

April 15-16, 2019 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC

April 16-17, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

April 11-12, 2019 - EU IVDR Implementation
Washington, DC

May 21-22, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June 4-5, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Boston, MA

OctoberOctober 22-23, 2019 - Global Regulatory Strategy
Washington, DC

OctoberOctober 23-24, 2019 - MedTech M&A: Regulatory & Quality Due Diligence
Washington, DC

NovemberNovember 13-14, 2019 - India - the MedTech Market: Strategic Planning & Practical Considerations
Washington, DC

LinkedIn Facebook Twitter YouTube