MEDICAL DEVICE CONSULTING
Product Development, Quality, Regulatory & Marketing
We provide product development, quality, regulatory, and marketing services. We are experts in all device types and classes but are particularly passionate about connected devices, software as a medical device (SaMD), and digital health products that are driven by AI & Machine Learning. We can support your quality system implementation needs, Q-sub, De Novo, 510(k) applications and help you get US FDA market clearance. We can also support your regulatory clearance in almost any other country. Our preference is to work with early-stage to mid-size companies.
Contact us and see if we can help.
RAC Medical provides a one-stop-shop for all your healthcare product development needs. We have developed or supported the development across a range of medical devices from Class I to Class III to General Wellness type devices. We specialize in both hardware and software, including mobile apps and cloud-based solutions driven by AI/Machine learning. We provide guidance and strategy from development, to product testing, to quality regulatory compliance for US and OUS commercialization.
We provides services to support you from Concept to Commercialization, including Project Management to Design and Development Engineering (hardware and software).
QUALITY SYSTEM IMPLEMENTATION
21 CFR 820
EN ISO 13485:2016
ISO 14971 (all versions)
Regulatory support for all regions including the U.S. (Q-subs, 510(k), De Novo etc.), Canada, EU and more. Contact for more details
SAFETY & COMPLIANCE
Guidance and support for all applicable product safety and compliance standards and testing.
Guidance and support for U.S. and international clinical study planning, design, and execution.
Support, planning, and implementing formative and/or summative usability testing.
Lead the full prototype design and development efforts (industrial design, electrical, mechanical, firmware, and iOS) for a new medical device. The Class II medical device is a hand-held electro-mechanical device connected to an RMC designed and developed custom mobile iOS app.
PRODUCT DEVELOPMENT SUPPORT
Drive the strategy and support implementation of product definition, risk analysis, design guidance, and design verification and validation activities.
Support supplier selection and evaluation.
Implement a quality system for an early stage medical company developing a novel imaging system.
QUALITY & REGULATORY SUPPORT
Implement a quality management system in compliance to 21 CFR 820 and ISO 13485 for an early-stage medical device company developing a Class II women's health product.
Implement regulatory strategy and successfully lead FDA 510(k) clearance efforts.
PRODUCT DEVELOPMENT SUPPORT
Support product development activities for early-stage startup developing a novel wearable device.
Quality system implementation in compliance with 21 CFR 820 and ISO 13485:2012
Regulatory strategy support and successful FDA 510(k) submission and clearance under the average time for similar devices.
QUALITY & REGULATORY SERVICES
Quality system implementation for early-stage startup developing a novel cloud-based software solution for medical imaging.
Provided regulatory strategy and authored FDA 510(k) submission. Clearance received under average device clearance time frame.
Led the efforts for ISO 13485:2016 certification.