Question
The DIS2 of the ISO 13485 now and projected for the release in end 2015.Why not scrap this project, let the ISOTC210 take due time and come up with the ISO 13485: 201x aligned to the ISO 9001: 2015 on the lines of the HLS.Any standard must standardiz...
Good or bad? The US House-approved "21st Century Cures Act" (now on its way to the Senate) tries to reduce the costs of bringing treatments to the patients that need them. Here's a link to the short US Energy and Commerce Committee paper which recomm...
Joseph Patrissi
Sr. Enterprise Sales Executive at Auriga - Software Engineering Services since 1990
July 2015
Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
Billing itself as "the world's first maskless, hoseless, cordless, micro-CPAP device," startup Airing made a stir with its crowdfunding campaign this month, raising $800,000+ and attracting 4,000+ patients hoping to try the product as early as July 2...
Someone told me that it's possible for a med device company to use their contract manufacturer's ENTIRE quality system as their own. He said since design and development is outsourced, his company could just use all of the manufacturer's procedures a...
Dean Harper
Driving the business forward through culture change, Lean Six Sigma tools and techniques.
July 2015
Does anyone know if there are any hard and fast rules around validation of a filling line used for dispensing medical diagnostic reagents. For example how many bottles should you test during PQ if your typical batch size is to be 5000?source: https:/...
How common are random FDA audits for device manufacturers? Does the FDA focus mainly on class 3 device companies? Do they ever randomly audit contract manufacturers? Can anyone share any insight into this topic for me? As always I appreciate your com...
Is the biomedical engineering technician community still striving to become a recognized profession?
Several years ago, there was a great push from the biomed community to become a profession. What is the status on that pursuit now?source: https://www.linkedin.com/groups/78665/78665-6023992469094412289
My neighbors son has Duchenne muscular dystrophy. He was diagnosed at the age of 4 and at the time his father could not find a scooter that his son could use. So he designed and built a scooter that helps him get around and more importantly helps him...
