Zimmer Biomet Gets FDA Clearance for
Persona Revision Knee System

By MedTech Intelligence Staff

A U.S. launch of the product is expected in just a few weeks.

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A critical misunderstanding threatens Class I device manufacturers: As the end of the Medical Device Regulation’s (MDR) transition period, set for May 26, 2020, steadily beckons, there is a mistaken belief that that the need to comply with the EU MDR only applies to businesses manufacturing higher risk devices.

— Peter Rose, Maetrics

MEDdesign

Developing Endoscopic Technology To Save Cost
and Time Constraints

By Marc Levinson, EndoVentions Medical

Minimally invasive surgical endoscopes can tackle both the challenges of cost as well as durability.

Out with the Old, FDA Recommends Use of Duodenoscopes with Innovative Designs

By MedTech Intelligence Staff

The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.

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

Medical Device Cybersecurity:

Legacy Device Remediation, Compensating Control & End-of-Life Conference, September 26-27, 2019

Plan to attend this Workshop at the Medical Device Interoperability & Cybersecurity Lab at MGH, Boston, MA or "virtually" from your own location via a webcast.

This highly interactive program is intended to help manufacturers and hospitals – independently and in collaboration – better understand steps they can take to improve medical device cybersecurity throughout the product life cycle.

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EU MDR: REQUIREMENTS & IMPLEMENTATION

THIS EVENT WAS RECORDED JULY 17, 2019 | On Demand Webcast

This on-demand recording of the four-hour virtual event that took place July 17, 2019, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes. The four hour webcast recording is $495.00

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ADVANCED CAPA & ROOT CAUSE ANALYSIS

THIS EVENT WAS RECORDED MARCH 26-27, 2019

CAPA is the most critical and challenging quality system requirement in terms of complex thinking and organizational processes. How do you verify effectiveness? How can you apply project management to CAPA? What are the right data and tools for identifying trends? How do you deal with significant but infrequent problems? Should you set deadlines for closing CAPAs, and what about CAPAs that never close? What are best practices for documenting and communicating CAPA results? Not a CAPA 101 course, this workshop recording brings together leading industry CAPA process owners to discuss approaches to the most difficult problems in CAPA and root cause analysis.

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