Q&A:
MedTech Industry Still Scrambling as MDR Deadline Nears

By Maria Fontanazza, Editor-in-Chief

With May 26, 2020 quickly approaching, every day counts.

Evolve Your Commercial Approach to Meet Needs of
a Changing Customer Base

By Ed Park, Decision Resources Group

Medtech companies must account for a more complex web of influencers on purchasing.

PerkinElmer Wins FDA Authorization for First Newborn Screening Test for Duchenne Muscular Dystrophy

By MedTech Intelligence Staff

The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.

Featured Quote

From the perspective of healthcare workers, the exposure to nitrogen dioxide was considered most likely to occur in the case of cylinder leaks. Damaged gas supply lines and damage to the gas cylinder regulator were other possible scenarios for exposure of the healthcare worker to nitrogen dioxide.

— Henry Szymanski Marketing Consultant

MEDdesign

Regenerative Medicine:
Innovative Approach Reduces Burn and Diabetic Wound Complications

By Bill Oldham and Robin Robinson, Ph.D., Thought Leadership & Innovation Foundation

The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.

Manufactured by Boston Scientific, FDA Clears First Single-Use Duodenoscope

By MedTech Intelligence Staff

The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.

Soapbox

Satisfying the Market’s Growing Appetite for
Product Data

By Frits Stulp,
Iperion Life Sciences Consultancy

Whatever the demands of international regulators, it is public expectations that will ultimately dictate the need for life sciences companies to prepare complete and accurate product data that patients and healthcare providers can scrutinize on demand.

Ameing for Asia

Asian Giants Gain Medical Robotics Foothold

By Ames Gross, Pacific Bridge Medical

Across the continent, governments and hospitals are purchasing robotics systems from abroad as well as developing the technologies themselves.

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

EU-MDR Implementation Strategies Web Seminar

February 4-6, 2020

Anyone can read the regulation, but interpretation remains vague in some areas, and even the best prepared companies have large teams struggling with impact analysis, strategy, budgeting, and implementation. This three half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies. Pooling knowledge and strategies will help the industry as a whole better plan for the massive and costly upcoming changes.

Register Now at www.EU-MDR.events

EU MDR Risk Management Web Seminar

February 18-19, 2020

This two half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies.

Topics covered:

• Introduction and Overview - Risk Management and the EU MDR
• ISO 14971:2019 – Overview and Applicability to EU MDR and other regions
• Design and Usability Requirements with respect to EU MDR
• Practical application of Risk Management for EU MDR
• EU MDR and Post Market Surveillance Requirements
• EU MDR additional Monitoring and Trending Requirements
• Post Market Surveillance methods and best practices
• Post Market Surveillance and Risk Management
• Application of Risk Management for Post Market Surveillance and Trending
• Tying it all together - EU MDR / Risk Management / Post Market Surveillance

Register Now at www.EU-MDR.events

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.

More Info