Posts categorized as“Regulatory”

Nick Allan

10 things I learned from Bad Blood

What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device Bad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of my 2018 summer fun reading list.  It was released in May 2018 and written by John Carreyrou (the two […]

Clara Li

Navigating Medical Device International Regulations

Bringing medical devices to market in a single country can be a regulatory challenge. The process often becomes much more complex when marketing in multiple countries and navigating medical device international regulations. A comprehensive understanding of current regulations in each country of interest is required as device laws and regulations are constantly changing. If you’re […]

Astero StarFish

Avoid these 11 costly medical device development mistakes

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 […]

Mike Sanders

Medical Devices and GDPR (the EU General Data Protection Regulation)

With an enforcement date of May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) is about to impact medical device manufacturers. Though similar to the U.S. Health Insurance Portability and Accountability Act (HIPAA), the new GDPR requirements will influence medical device data services by enhancing privacy and security for EU citizens.

Astero StarFish

Medtech resolutions for 2018

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 […]

Yoav Raiter

How blockchain technology will change the medical device industry

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 […]

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