The Convergence in Healthcare and How Small and Large MedTech Companies Must Adjust

By Maria Fontanazza, Editor-in-Chief

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

Q3 European Medtech Deals Up Nearly 13%

By MedTech Intelligence Staff

Eighty medtech transactions in Europe came in at a value of approximately $627.5 million.

Take a Closer Look at the Components in Microfluidic Devices

Manufacturing microfluidic devices requires sophisticated techniques.

Featured Quote

As ISO Identification of Medicinal Products (IDMP) compliance plans are refreshed in the light of new movement towards implementing the product data standards across the European Union, life sciences companies find themselves at an important crossroads.

— Frits Stulp Iperion Life Sciences Consultancy

Reimagining Eye Care
in Asia

By Mary Kan and William Greene,
Singapore Biodesign

The future of eye care will sit at the intersection of the digital and physical worlds.

Soapbox

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer, Greenlight Guru

Drop the checkbox mentality and embrace accountability and understanding.

• 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