Software Compliance Training and Services For Software as a Medical Device (SaMD)
HOW CAN WE HELP?
Lean and effective software quality processes for the medical device industry.
We provide a comprehensive range of software quality and compliance services to the medical device industry and we focus on Software as a Medical Device (SaMD) and medical device software.
We can implement processes and procedures pertaining to ISO 13485, software life cycle (IEC 62304), risk management (ISO 14971), and Cybersecurity processes. We can also audit your design history and technical files and perform a gap assessment against the required standards.
Ranj Zuhdi, MS, is the founder and principal consultant at SDLC Compliance Ltd.
He is an expert in SaMD (Software as Medical Device) compliance.
With 17 years of experience in the medical device and digital health space, Ranj's expertise ranges in implementing software quality system compliant with ISO 13485 and FDA’s Quality System Regulation, ISO and IEC standards, Agile development and testing, risk management, verification and validation strategy, and cybersecurity topics.
“Really enhanced our teams' understanding of the new regulations. Ranj was able to provide both breadth and depth of knowledge on the topic and make something complex so understandable"
Dr. Paul Campbell
Clinical Director of eHealth
The path to regulatory approval can be long and complex. We understand that software development is different from traditional waterfall medical device development. Implementing a Quality Management System (QMS) for software as a medical device (SaMD) does not need to be cumbersome and costly.
We take into account the iterative and agile nature of your design life cycle and the size of your team. We will advise, develop and deliver procedures strategic support unique to your culture while staying compliant to ISO/IEC and FDA requirements.
New to Medical Device Regulations or starting a new SaMD project?
- We will provide you a clear and robust strategy for your QMS setup so you can plan for resources and cost early on in your project.
- We offer workshops and trainings in the following areas: ISO 13485, Design and Development of SaMD, Software Life Cycle, and Safety and Security Risk Management.
There’s no need to worry about navigating the complicated regulatory and compliance frameworks mHealth apps involve. Our expert team is on hand to make sure you reach your goals.
Contact us today to find out how we can help.
Tel: +44 75 3852 5557 (UK) +1 (818) 270 7888(US)