Medical Device Development

A BROAD RANGE OF MEDICAL DEVICE DEVELOPMENT EXPERTISE

NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO-certified (ISO13485-2003) quality management system (QMS) covers a five-phase product development process from concept through manufacturing transfer, including controlled builds for preclinical and clinical trial devices.

Our senior-level device engineering team works with our clients to establish a project plan that incorporates ISO-compliant documentation, regulatory submittals, clinical trials, V&V testing, and other regulated device development considerations, along with typical electro-mechanical device development activities. Our familiarity with a wide range of medical and non-medical devices, and our in-house development tools that include onsite rapid prototyping, CNC machining, and environmental testing are an asset to both our startup medical device clients and established product companies.

General Medical Device Development Services

  • ISO 13485-certified
  • Development of verifiable design input requirements
  • Concept development
  • Functional, marketing, and clinical trial prototypes
  • Risk and hazard analysis and FMECA
  • Device detail design and development
  • Preclinical trial management
  • Biocompatibility and toxicity test management
  • Sterilization validation
  • Device verification testing and software validation testing
  • Industrial design (ID), human factors (HF), and user interface (UI) design
  • Design control and DHF documentation
  • Compliance with ISO, IEC, FDA QSR
  • Process validation and automated test equipment (ATE) qualification

Specific Medical Device Experience

NOVO’s medical device development team has experience with the following therapeutic and surgical device types: