3M - Covering a device? Make it stick.

MedTech Intelligence

Volume 12 Issue No. 02


Gerard von Hoffman, Knobbe MartensProtecting IP Should Remain a Critical Part of Medtech Business Strategy

By Maria Fontanazza, Editor-in-Chief

A look at IP litigation in 2019 and the year ahead, and some advice on how medical device companies can safeguard their intellectual property.


Crescent Industries - Engineering-Driven, Manufacturing-Driven Technology-Based Injection Molding Partner!

Featured Articles

Alan Grau, SectigoSecuring Medical Devices: What is Really Needed?

By Alan Grau, Sectigo

It’s time for medtech design engineers to take a page from the enterprise security playbook.

Will You Be Able to Sell Your Medical Device in Europe after May 26?EU MDR:
Will You Be Able to Sell Your Medical Device in Europe
after May 26?

By MedTech Intelligence Staff

This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.

Peter Micca, DeloitteThe Convergence in Healthcare and How Small and Large MedTech Companies Must Adjust

By Maria Fontanazza

Peter Micca of Deloitte discusses the changes that are happening within the healthcare ecosystem as a whole.

Developing a Mobile Medical Device? FDA Is WatchingDeveloping a Mobile Medical Device? FDA Is Watching

By Amy Scanlin, EAS Consulting, LLC

Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.

From the Archives

Maria Fontanazza, Editor-in-ChiefFuture Trends in Usability:
Virtual Reality and
Adaptive Systems

By Maria Fontanazza

Human factors engineering and the tools companies can leverage will get way more sophisticated.

Loftware - Successfully Manage Labeling & Compliance for MDR

Siemens - Live Webinar about MedTech digitalization

Accumold - Micro-Mold - Small Mold - Lead Frame/Insert

EU MDR Implementation Strategies

EU MDR Risk Management Web Series - February 18-19, 2020

Resource Centers

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

QServe: Your MedTech Partner for Regulatory, Quality Affairs, and Clinical Trials

Sponsored Resources

SiemensSiemens Live Webinar about MedTech digitalization

MedTech companies must navigate the question of how their digital evolution will take place. Attend this webinar to discover the role of best-in-class and integrated software solutions for Manufacturing Operations Management (MOM) and explore the key benefits they generate for Medical Device and Diagnostics (MD&D) firms.

Register now


EU MDR Web SeminarsEU-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 Web SeminarsEU 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




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

Upcoming Events & Webinars

FebFebruary 4-6, 2020 - EU MDR Implementation Strategies
Virtual Events

FebFebruary 18-19, 2020 - EU MDR Risk Management
Virtual Events

MarMarch 3 & 10, 2020 - Technical Writing Virtual Workshop
Virtual Events

AprApril 8 & 22, 2020 - Events Reports Virtual Workshop
Virtual Events

MayMay 6 & 20, 2020 - Six-Sigma CAPA Virtual Workshop
Virtual Events

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