Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
-
RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.
-
Medical device artificial intelligence (AI) overview of AI, applications and devices, investment landscape, and regulatory implications.
-
Biotech in medical device companies: 3 compelling reasons to pursue a Bio Services career in medical devices.
-
Overview of battery safety for medical devices addressing design issues related to size, form, capacity and performance demands on batteries.
-
Round up of Top 10 COVID-19 medical innovations from robotics to COVID 19 POC Diagnostic Tools, PPEs, and Portable dialysis machines.
-
Ingress protection for home healthcare medical devices covers the 60601-1-11 collateral standard and what developers should know.
-
COVID-19 Ventilator Design team discuss their top insights and lessons learned from the time constrained, critical ventilator project.
-
Author describes her experience submitting a medical device application (ventilator) under the Health Canada Interim Order.
-
The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.
