Software certificationThis track focuses on the issue of certification for modern medical devices. These devices rely more and more on software and are paradigmatic examples of safety critical systems. Existing approaches to software safety and certification are invariably process based; at best, this ...
Data Security:HIPAA/HITRUST compliance, ISO-13485 certified for medical device development, ISO-9001 certification for quality management, ISO-27001 certification for information security standard Customers of Glorium Technologies:CAE Healthcare, AGFA Healthcare, REALPAGE, control.IT, BBMK Technologies, m....
The recent introduction of EU MDR brought many changes to the CE marking certification process for medical devices. There are more requirements to fulfil, which makes the process more complex and much more time-consuming. To avoid a scenario where the only thing that stops you from releasing you...
As a manufacturer of software as a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in theMedical Device Regulation (MDR) (EU) 2017/745and, for the UK, theUK Medical Devices Regulat...
Medical Device Regulation 2017/745 (MDR).#The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certification process essential for obtaining a Conformit茅 Europ茅enne (CE) marking for Class IIa medical device ...
Source: Food and drug administration, "FDA selects participants for new digital health software pre-certification pilot program" Principles and solutions for a new regulatory framework Ideally, the new regulatory framework for software as a medical device would include ongoing collaboration among key...
Optimized for all devices Nothing to download Instant patient Recs Secure payments Coupons Referral System Take a Tour Technology Integrations Latest News Read some of the latest Verify MC medical marijuana software news below to stay up to date ...
Medical devices have also become a popular target for hackers. Security breachesdoubled in the first six months of 2020compared to the same period last year. Ultimately, security is a never-ending process that requires secure software development and secure communications from the operating sys...
LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development.
The IEC 62304 standard specifies a set of processes, activities, and tasks that establish a common framework for designing safe and tested software for medical devices. The standard categorizes software into three safety classes according to the consequences to the patient from a possible software fa...