Medical Devices

Solve Non-conformance & Bring Your Product into Compliance

Engineering and regulatory experts that support your product development with audit preparations, market launches, medical device certifications (such as CE and NRTL), and hardware and embedded software development.

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

To support formal certification of your project with regulatory authorities (such as the FAA, EASA, FDA, Health Canada and NRTL) Aversan provides artifact creation, documentation management, and process development.

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.

Capabilities

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)

Full Service

A single source from design concept through product delivery management

Flexibility

Nimble, customizable teams quickly ramped up to support specialized needs

Expertise

Experienced management, software, electrical, FPGA, and mechanical engineering professionals

Continual Risk Assessments

Constant evaluation of technical, regulatory, and competitive factors with a focus on Reliability, Availability

Test-Driven Design and Development

Shorter development cycles through early identification of gaps and automated testing coverage

Compliance Expertise

Navigating regulatory frameworks and understanding device specific requirements

Featured Projects

Medical Device Automated Test Equipment – Laborie

Aversan was chosen by Laborie Medical Technologies to automate the verification & validation efforts pertaining to Laborie’s medical devices.