Soapbox

Four Ways to Approach the Medical Device Sterilization Predicament in an Election Year

By Chaun Powell and Soumi Saha, Premier, Inc.

2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation.

The Future of Diabetes Management in Asia

By Jonathan Chan, Healthcare Writer

A more comprehensive management approach is needed to tackle the rising threat of diabetes in the region.

Teaming Up to Deliver Game-Changing Solutions for People with Chronic Disease

By Jeff Andrews, Eli Lilly and Company

Pharma and Tech Working in Sync to Enhance Health.

Technical Writing Workshop Focuses on Key Elements for Lifescience Companies

By MedTech Intelligence Staff

This two-part virtual workshop will guide participants through the process of how to write effective documents.

Featured Quote

The significant change to the Special 510(k) Program involves eligibility factors.

— Tara Lysechko, Starfish Medical

Soapbox

IVDR: Go with the Flow

By Sue Spencer, Qserve

When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.

Be Prepared for Accelerated Adoption of AI in Wearables

By Maria Fontanazza, Editor-in-Chief

Personalized medicine is the future of healthcare, and artificial intelligence will play a big role.

Soapbox

Lack of Operational Medtech Equipment in Developing World

By Leslie Calman Ph.D. and, Jessica Baker, Engineering World Health

Having trained biomedical equipment technicians in developing regions can help, but lack of funding is perpetuating a dire situation.

• 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