Posts categorized as“Quality”

There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]

The New Year brings reflection and desire to improve.  We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]

The top 10 StarFish Medical blogs of 2017 feature a heady mix of regulatory, engineering, and practical information and advice. Seven of the blogs are perennial favorites with high ranking on Google and other search engines. The remaining three are from new writers and hint of new evergreen standards in the works.  New or tried […]

The StarFish Medical newsletter features a monthly collection of medical device articles, images, events and videos. We aim to share our knowledge and expertise to all levels of medical device colleagues. Once a year we share what was hot with our readers. Just in case you missed that issue. Below are our Top 10 reads […]

We love creating StarFish Medical videos to help viewers learn about medical device design, development and manufacture.  We also appreciate the opportunity to showcase our talented team. It’s a great way to get a better sense of the people you will be partnering with at StarFish. The top 10 viewed Starfish Medical videos for 2017 […]

There is no question whether ISO 13485:2016 section 7 changes will impact your Quality Management System (QMS). In my previous blog I stated that the two major themes in changes to the ISO 13485 standard are taking a risk based approach and documenting everything. They are also two of the core differences in section 7, […]

The value of competence and training in developing and maintaining a quality workforce is well understood. Yet, many organizations struggle with providing, documenting, and evaluating the effectiveness of their training efforts. This is often revealed in audit findings that point to deficiencies such as a lack of establishing procedures for training and identifying training needs, […]

From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing […]