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 serious injury or death.... Read More

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... Read More

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 a brand-new... Read More

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. Read More

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

Is your business challenged by a complex and ever changing global regulatory environment? Medpoint can help! Read More

Medpoint is seeking Quality Engineering candidates interested in contract work or permanent placement opportunities in various locations. We have a need for all levels of expertise. Experience in Medical Device and Pharmaceutical industries is preferred, but Quality Engineers with experience in other industries are also welcome. For consideration, please submit your information and CV via our... Read More

In a move that pharmaceutical companies are sure watch closely, Ohio Attorney General Mike DeWine officially filed a lawsuit on May 31 against Purdue Pharma L.P., Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Allergan PLC, and Endo International PLC’s Endo Health Solutions Unit. The suit alleges that the practices of these companies, particularly their marketing of opioid pain killers,... Read More

When it comes to health, prevention is naturally preferred to treatment. For stroke victims, recent medical device advances are providing the hope of preventing future attacks. Both the Watchman (approved for Boston Scientific by the FDA in 2015) and the Amplatzer PFO Occluder (approved for St. Jude in 2016) work to stop blood clots from reaching the heart and are already being used with success.... Read More

In 2016, the ever rising cost of healthcare generated some of the most intense public and political debates. Perhaps in no way was this better summarized than the sudden – and shocking – rise in the price of the EpiPen, a life-saving device dispensing epinephrine for the severely allergic. From a price of $100 in 2007, the cost skyrocketed to over $600 last summer. Consumers were outraged,... Read More