While there were some minor changes regarding Management Responsibility in the latest revision to ISO 13485, the expectations for top management commitment remain as important as ever. The active involvement of top management is crucial to ensuring the continued relevance and success of your company’s Quality Management System. Whether you are new to management responsibilities or have been handling them… Read More
Airline Fatality Provides Sobering Quality Reminder
The quality community received a sobering reminder recently of the importance of their work when Southwest Airlines flight 1380 had an engine suddenly explode soon after takeoff. While the pilot was able to safely land the crippled plane, there was one passenger fatality – the first on a United States airline since 2009. There will of course be a detailed… Read More
Effective Management of Medical Device and Pharmaceutical Recalls
Product recalls are an unfortunate part of any manufacturing industry. For medical devices and pharmaceuticals, recalls are serious affairs requiring swift corrective action. Each year, an average of 4,500 drugs and devices are removed from the market due to recall. In 2017, the FDA identified more than 30 Class I recalls, where further use of the product could result in… Read More
MDSAP – Are You Ready?
The Medical Device Single Audit Program, better known by its acronym MDSAP, is designed to increase audit efficiency by allowing a single audit to cover the requirements for Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, the U.S. Food and Drug Administration (FDA), and Japan Ordinance on Standards for Manufacturing Control. Although this… Read More
Four Tips for Building an Effective Quality Management System
A robust quality management system (QMS) is important to every company, but just as no two companies are the same, no two quality management systems can be identical either. It is important to ensure that the system you develop serves the needs of your company specifically, improving operations and mitigating risk, not just fulfilling quality requirements. Whether you are building… Read More
Are Your Supplier Controls FDA Ready?
You depend on your suppliers to provide quality products, but each supplier represents a risk. If you are registered to 21 CFR 820, there are strict FDA guidelines in place governing expectations for supplier controls. Medpoint offers several services to help you prepare for an FDA audit and avoid the time and expense of responding to FDA findings that drain… Read More
Why Lean Six Sigma?
By now, you’ve likely heard about Lean Six Sigma. But in today’s hectic business world, time and money are limited resources, so what is the cost benefit of Lean Six Sigma training? One common misconception is that Lean Six Sigma is useful only for manufacturers. In reality, the practices of Six Sigma training can be utilized across every business type…. Read More
Advance Your Career with Lean Six Sigma Certifications
Are you looking to advance your career by earning your Lean Six Sigma Yellow Belt, Green Belt, or Black Belt? We have innovative and affordable professional workshops available so you can advance your career and/or deepen the knowledge of your team. Join the hundreds of professionals who have already received their Certification from Thayer School of Engineering at Dartmouth. The… Read More
Emerging Chinese Healthcare Market Presents Opportunities and Challenges
Among emerging markets in the medical device industry, China stands apart for its exceptionally rapid growth. From 2004 to 2014, healthcare spending in China has expanded from $90.8 billion to just over $590 billion. With FDA News declaring recently that opportunities in China are “better than ever,” major medical device manufacturers are scrambling to carve out their space in the burgeoning… Read More
Medpoint University Joins with Thayer School of Engineering at Dartmouth College and BlueSkye for Lean Six Sigma Online Courses
Thayer School of Engineering at Dartmouth College and BlueSkye Track are pleased to announce the launch of a new global collaboration with Medpoint University, a division of Medpoint, LLC, a leading provider of quality, regulatory, and clinical consulting and training services. The new partnership will support the establishment of an Online Global Campus to serve the needs of professionals and participants seeking certifications in the… Read More