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 […]
Posts categorized as“Manufacturing”
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 […]
Companies manufacturing equipment or consumer parts that use hazardous materials in the manufacturing process must comply with RoHS and REACH environment regulations. RoHS and REACH are two regulations that require compliance if a company intends to sell in the European Union, China, Korea and some parts of the United States and Canada. Therefore it is […]
As a medical product moves through development to production stage, establishing supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]
Often when a product design is completed and the design transfer to volume production begins, medical device developers run into a tsunami of issues that prevent them from meeting their planned build schedule and impact their capacity to meet forecasted sales.
Process Failure Modes and Effects Analysis (PFMEA) can be a powerful tool to identify potential failures in the manufacturing process of medical device, and help prioritize which failures should be improved first. However, the effort required to complete a PFMEA can take many hours, which costs money. Applying PFMEA efficiently will be addressed in this […]
A world class medtech supply chain is made on a foundation of controls, knowledge and planning. This blog takes a look at three key elements a seasoned buyer would use to achieve maximum potential: Lead Time, Quoting/Planning, Paperwork Accuracy.
Understanding the Basics of Adhesives Selecting wearable medical device adhesives requires a solid understanding of the basics of adhesive. Sticking a medical device to skin is not as simple as it sounds. Numerous variables come into play such as the patient’s age, gender, race, diet, activity, skin condition, and climate. Other variables include the stretchability […]
The Conformité Européenne (CE) mark is a common sight on products in North America, and Europe. However the China Export mark and CE mark are easily confused, which is understandable because they look almost identical. This similarity is something which has been acknowledged by the EU parliament.