Blockchain technology introduces new secured measures for keeping authentic and anonymously real time personal data in decentralized manner. It can be expected that upon maturity the blockchain technology behind Bitcoin will gain the required trust and be used extensively by partners of the highly regulated healthcare ecosystems: patients, regulators, clinics, pharmacies, insurers, laboratories, technology developers etc.
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 and true, these 10 StarFIsh Medical blogs are worth reading and sharing.
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 of 2017. They reflect the diversity and talents of our employees, clients, and readers.
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 include 4 new videos and several favorites from previous years. Want to see them sooner? Subscribe to our Youtube channel or newsletter!
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 important to know which vendors possess compliance.
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 to the proportionate risk associated with the medical device.
Here are some tips to help you meet regulatory requirements around supplier controls and to de-risk your supply chain.
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 blog.
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.
Saturday night I won the Technology category of the EY Entrepreneur Of The Year™ 2017 Pacific Awards ceremony held in Vancouver BC. I’m sharing my acceptance speech video with our blog readers who are entrepreneurs or about to embark on the journey. To me, the award is a team award for what we’ve achieved together because StarFish and ViVitro are really about team effort.
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, “Product Realization”.