Product Development Services
Engineering Support for Medical Device & IVD Development.
Bringing a regulated medical device or IVD from concept to market requires specialized engineering expertise that most small teams and startups don’t have in-house.
Whether you’re a founder navigating your first FDA submission, an engineer managing multiple development projects, or a growing company expanding into new markets, you need partners who understand the technical complexities and the regulatory requirements.
AJW Technology Consultants provides end-to-end product development support for medical device and IVD manufacturers. Our team of engineers and development professionals has two decades of experience in regulated industries, helping companies through the entire product lifecycle from early concept through post-market requirements.
How We Support Your Product Development Journey
Medical device development is rarely linear. Depending on where you are, you may need regulatory pathway guidance, hands-on engineering support, or validation planning.
Early Stage: Concept to Feasibility
When you’re evaluating whether a device concept is technically and regulatory feasible, we help you answer key questions before investing: What regulatory pathway makes sense? What are the technical risks? What standards apply?
- Product concept evaluation and feasibility assessments
- Regulatory pathway determination (510(k), PMA, De Novo, EU MDR, EU IVDR)
- Initial risk management planning (ISO 14971)
- Design requirements development
- Product definition and visual/concept design
Design and Development: Building to Regulatory Standards
Full lifecycle support: planning, requirements, coding, configuration management, and testing for embedded systems, standalone software, and mobile applications. FDA and IEC 62304 compliant.
Design Engineering and Electrical Safety
Electrical engineering, mechanical engineering, prototyping, and CAD services. Experienced with IEC 60601-1 (3rd edition), PEMS documentation, and RoHS compliance for medical equipment.
Risk Management
Risk management programs, procedures, and design risk analysis for hardware and software products. Post-market surveillance systems according to ISO 14971 and IEC 62304.
Human Factors Engineering (Usability)
Usability procedures, formative and summative testing, and human factors reports for FDA and EU MDR/IVDR compliance. Standards: IEC 62366-1, ANSI/AAMI HE75, IEC 60601-1-6.
Biocompatibility Evaluations
Guidance on ISO 10993 requirements for devices with patient contact, including biological evaluation planning and testing strategy.
Verification and Validation: Proving Your Design
Design control under 21 CFR Part 820.30 and ISO 13485:2016 requires documented evidence that your device meets requirements and user needs. We help plan and execute the testing regulatory bodies expect.
- Design verification and validation planning
- Test protocol development and execution
- Design history file (DHF) preparation
- Electrical Safety and EMC testing (IEC 60601-1 & IEC 60601-1-2)
- Technical documentation compilation
- Sterilization validation
Regulatory Submission: Getting to Market
Preparing FDA 510(k)s or EU MDR/IVDR technical documentation requires meticulous regulatory expertise. We’ve supported successful FDA clearances and CE marking across cardiac monitoring, pulse oximetry, orthopedic implants, electrosurgical equipment, robotic surgical systems, endoscopic instrumentation, and respiratory products.
- Technical documentation compilation and review
- Gap assessments for regulatory readiness
- Design dossier preparation for EU MDR and EU IVDR
- 510(k), PMA, and De Novo application support
- Post-market clinical follow-up (PMCF) planning
Post-Market: Maintaining Compliance
Regulatory obligations continue after clearance. Post-market surveillance, vigilance reporting, and design changes all require ongoing support.
- CAPA support
- Post-market surveillance systems
- Post-market clinical follow-up (PMCF) for EU MDR/IVDR
- Design change management
Why Development Teams Choose AJW
Most medical device startups and small manufacturers can’t justify hiring full-time specialists in software validation, electrical safety, human factors, and regulatory affairs. But they still need this expertise to bring products to market.
We provide senior-level engineering and regulatory expertise as an extension of your team. You get experienced professionals who understand FDA requirements, EU MDR, EU IVDR, and international standards without the overhead of full-time hires.
Our expertise includes:
- FDA QMSR
- FDA 21 CFR Part 820.30 (Design Controls)
- ISO 13485:2016 (Quality Management Systems)
- EU MDR 2017/745 and EU IVDR 2017/746
- IEC 62304 (Medical Device Software)
- IEC 60601 series (Medical Electrical Equipment)
- ISO 14971 (Risk Management)
- IEC 62366-1 (Human Factors/Usability)
- ISO 10993 (Biocompatibility)