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)

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

Electrical Safety – IEC 60601, IEC 61010
Usability IEC 62366
Human Factors HE75
Risk Management ISO 14971
CEC Requirements

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, FPGA, electrical, and mechanical engineering professionals

Continual Risk Assessments

Constant evaluation of technical, regulatory, and competitive factors

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

Learn more about medical device products and services.

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