Medical Device Software and SaMD Compliance

Ensuring Compliance with IEC 62304 Across Medical Device Software and SaMD

As the Medical Device Software Industry pivots to take full advantage of the advances made by Artificial Intelligence. LFH Regulatory is here to provide you with comprehensive consultancy and support to take your Medical Device Software and Software as a Medical Device (SaMD) innovations to market in a compliant and efficient manner.

Rapid advancement of technology presents opportunities and unique challenges when it comes to compliance with regulatory standards. That is why we have developed a specialised service that focuses on helping companies successfully navigate the requirements outlined in IEC 62304. This ensures your products can enter the market, fully compliant, faster.  

Compliance Made Easy

Contact the LFH team today to take the stress out of Medical Device Compliance

Understanding the Product Life Cycle for Medical Devices

Bringing a medical device to market involves a series of interconnected stages known as the product life cycle. These stages are concept, planning, design, validation, launch, and post-launch market activities. Each phase is critical to the success and compliance of your medical device, and we can help you every step of the way. 

How LFH Regulatory Can Help

Concept Phase

During the concept phase, LFH Regulatory can assist you in evaluating the feasibility and regulatory implications of your product. We provide expert guidance in assessing potential risks, compliance requirements, and strategic considerations to ensure a solid foundation for your project.

Design Phase

LFH Regulatory plays a crucial role in the design phase, ensuring that your software development processes align with the requirements of IEC 62304 and ISO 13485. We provide consultancy and support in defining software requirements, establishing design controls, and implementing effective risk management strategies. Our experts work hand-in-hand with your team to develop software architecture and facilitate compliance-driven design decisions.

Planning Phase

In the planning phase, LFH Regulatory works closely with your team to develop a comprehensive regulatory strategy. We help identify applicable regulations, standards, and guidelines that pertain to your software or AI (Artificial Intelligence) driven medical devices. Our experts assist in creating a detailed project plan that encompasses compliance milestones, resource allocation, and risk management.

Validation Phase

Validating the software is a vital step in the compliance journey. LFH Regulatory assists in developing validation plans, protocols, and test strategies to verify the functionality, performance, and safety of your medical device software. Our team provides guidance on conducting rigorous testing, analysing results, and documenting validation activities in line with IEC 62304 and ISO 13485 requirements.

Launch Phase

When your product is ready for launch, LFH Regulatory ensures that your regulatory submissions comply with the necessary regulations and guidelines. We review and optimise submission documents, addressing any compliance concerns or gaps. Our experts provide guidance on labelling requirements, instructions for use, and post-market surveillance obligations to streamline the launch process.

Post-Launch Market Activities

After your product hits the market, LFH Regulatory continues to support you in post-launch activities. We assist in establishing post-market surveillance procedures, including adverse event reporting, complaint handling, and corrective actions. Our experts help you navigate regulatory inspections and audits, ensuring ongoing compliance with IEC 62304 and ISO 13485.

Get Your Medical Device Software To Market Sooner

You can't under estimate first to market advantage, don't let compliance hold your product back. Contact to LFH team today.

IEC 62304: Medical Device Software – Software Life Cycle Processes

IEC 62304 is an international standard that sets forth the requirements for the life cycle processes of medical device software. It provides a structured framework for the development, maintenance, and support of software used in medical devices. Compliance with this standard is essential for gaining regulatory approvals and ensuring patient safety. 

LFH Regulatory boasts a team of highly skilled professionals with in-depth knowledge of IEC 62304 and ISO 13485. This extensive experience in the medical device industry means we can offer a range of services to ensure your compliance with this standard, including: 

Consultancy and Gap Analysis:

  • Our experts assess your existing software development processes, identify non-compliance issues, and provide tailored recommendations to align practices with the requirements of IEC 62304. 

Documentation Support:

  • Accurate and well-documented processes are crucial for demonstrating compliance. LFH Regulatory assists in creating and organising the necessary documentation, including software development plans, risk management files, and validation reports. 

Regulatory Submission Assistance:

  • Preparing and submitting regulatory documentation can be a complex undertaking. LFH Regulatory provides support throughout the submission process, reviewing the required documents, addressing any compliance concerns, and facilitating a streamlined approval process. 

 

Why Choose LFH Regulatory

Take The Stress Out Of Medical Compliance

Contact the LFH Team Today for a Bespoke Compliance Strategy