Protecting 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.

Securing 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.

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.

Featured Quote

With the MDR deadline only months away, the industry is scrambling. There are three paths manufacturers can take.

— Sandi Schaible, WuXi Medical Device Testing

The 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 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.

Future 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.

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

Siemens 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 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