Turning a great idea or a great prototype into a certified medical device is a challenging and exciting undertaking. Whether you are a small company bringing a new product to market, or an existing company updating a product, the highly regulated nature of the medical device field adds challenges to your work not seen in other industries.
Regulatory experts and embedded systems engineers can help you meet your objectives while staying cost effective in a highly competitive market. Our engineering and regulatory experts develop Quality Systems for new companies, help with audit preparations, market launches and certifications like CE, NRTL (i.e. UL, TUV) and others. Aversan also develops electronic hardware and embedded software which meet the highest regulatory standards.
Meeting your next release is our priority. Our engineers can work remotely or within your team to provide expert consulting, or to simply bridge a resource gap.
QMS design and development (ISO 13485, FDA CFR 820)
QMS transitions to latest standards (ISO 13485:2016)
Regulatory support for global market launch
Certification support: Agent services, pre-compliance testing (CE Mark, NRTL Mark)
Software process lifecycle creation (IEC 62304)
Risk management development (ISO 14971)
Electrical Safety – IEC 60601, IEC 61010
Usability IEC 62366
Human Factors HE75
Risk Management ISO 14971
CEC Requirements
Design, review and traceability to standards
Mechanical Design and Build
Hardware Design and Build
Embedded Systems and Software Development
Verification and Validation
Design for Test (DFT) Consulting
Development to Quality Assurance and Safety standards
System Integration and EMR connectivity
Remain confident that your project will pass final software, hardware and electrical regulatory controls.
Aversan has over a decade of experience supporting customers with testing embedded systems to generate artifacts necessary for certification. Ranging from large-scale formal testing of multi-control systems in real-time simulation labs, to small teams performing software verification and validation, Aversan can handle projects of any size.
Artifact generation
Requirements documentation
Requirements and test traceability
Software development and verification and validation for DO-178 A/B/C/D and IEC 62304
Hardware development and verification and validation for DO-254 A/B/C/D and IEC 60601
Planning documentation (PHAC, PSAC)
Certification support: Agent services, pre-compliance testing (CE Mark, NRTL Mark)
Software process lifecycle creation (IEC 62304)
Risk management development (ISO 14971)
A single source from design concept through product delivery management
Nimble, customizable teams quickly ramped up to support specialized needs
Experienced management, software, electrical, FPGA, and mechanical engineering professionals
Constant evaluation of technical, regulatory, and competitive factors with a focus on Reliability, Availability
Shorter development cycles through early identification of gaps and automated testing coverage
Navigating regulatory frameworks and understanding device specific requirements