Software Compliance Services For mHealth, Medical Devices and SaMD
We will help you get FDA approval and CE mark for you Medical Device software and go to market faster.
"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 for eHealth
"We approached Ranj for general advice around medical device classification and regulatory issues in getting an AI product to market. In the short time we've known him he has provided invaluable advice. We found him to be very knowledgeable indeed and he clearly has a very good idea of how such products are able to navigate through a changing regulatory landscape. His understanding of European and American procedures is excellent. Moreover, Ranj seems to have an extensive network that he can draw upon to cover virtually every aspect from CE marking to device classification."
Dr. Manish Patel
CTO at Jiva.AI
"Our organization was extremely impressed with the manner in which SDLC Compliance entered our environment, assessed the needs of the business and helped with all elements of plan implementation. I would highly recommend SDLC Services for your compliance needs."
VP Quality & Regulatory
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 ISO standards.
We work with startups and established enterprises of every size, and we can guide you through every stage of software development, from initial design through risk management, design control, and the deployment of your device/software/application.
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 13 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.
While working at Verily, Google Life Sciences, Ranj participated in the FDA's Digital Health Pre-certification (Precert) Program. England
Prior to that, he worked as a Software Quality Engineer at multinational MedTech companies such as Medtronic, Stryker, and Amgen.
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/Agile nature of your design life cycle and the size of your team. We will develop and deliver procedures and documentation unique to your culture while staying compliant to ISO and FDA requirements. We only work on quality and compliance for medical device software and SaMD companies, making us the best choice to manage your medical device projects.
We work with various sized organizations (from startups to large multi-national companies) in providing strategy, training and Quality expertise and services pertaining to Medical Device Software Life Cycle (IEC 62304). Take a look below at the services we offer and get in touch to achieve immediate results.
NEW TO MEDTECH, OR STARTING A NEW SAMD PROJECT?
We will provide you a clear and robust strategy so you can plan for resources and cost early on in your project.
Creating a compliant and lean strategy for your Quality Management System (QMS) is important. Compliance deliverables should not hinder your agility and efficiency.
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)