Renaissance Medical Consulting
Advising MedTech firms on regulatory compliance, quality systems, and market access.
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About us
About us
Renaissance Medical Consulting
Based in Auckland, New Zealand, Renaissance Medical Consulting helps medical technology innovators navigate regulatory compliance, strengthen quality systems, and develop market access strategies. The firm brings together technical engineering expertise and regulatory insight to support startups and established companies across the MedTech ecosystem.
Regulatory Compliance
Our Specialization
Quality Systems & Risk Management
Market Access Strategy
Portfolio
IV-Syringe Pump Product Development Plan (PDP)
IV-Syringe Pump Product Development Plan (PDP)
Collaborated with colleagues from Fisher & Paykel Healthcare under an academic setting to develop and publish a Product Development Plan (PDP) for an Intravascular (IV) Syringe Pump. My primary responsibilities included drafting the Programmable Electrical Medical Systems (PEMS) documentation and the Risk Traceability Matrix (RTM), with additional exposure to:
Verification & Validation (V&V) activities
Quality Management Systems (QMS) documentation
Risk Assessment and Mitigation Strategies
User Needs and Design Input Specifications
Post-Market Surveillance Planning
The project aligned with international standards and regulatory frameworks, including:
ISO 13485:2016 – Quality Management Systems for medical devices
ISO 14971 – Risk Management for medical devices
IEC 62304 / IEC 62366-1 – Software and Usability Engineering
21 CFR Part 11/Part 820 – FDA regulations for medical devices
Alternating-Pressure Air Mattress (APAM) — Design & Compliance Case Study
Alternating-Pressure Air Mattress (APAM) — Design & Compliance Case Study
As part of an academic collaboration, I co-led the concept iteration and compliance framing for an Alternating-Pressure Air Mattress (APAM) designed to reduce the incidence of pressure ulcers in immobile patients. My role focused on consolidating six independent design concepts into a structured, traceable pathway that balanced patient safety, usability, and manufacturability.
Key contributions included:
Using Pugh analysis and Kano prioritization to evaluate and select critical features (safe working load, CPR compatibility, low-air-loss ventilation, quiet operation).
Iterating the design across multiple stages, from early sketches to a CAD-ready model with layered air cells, safety valves, and side-rail protection.
Embedding risk-aware design thinking, addressing potential hazards such as sudden power loss, overheating, and patient falls.
Considering quality-system principles like manufacturability, maintainability, and ease of training, to support long-term usability and market viability
Early-stage product development can benefit from integrating safety and compliance to create a clear foundation for compliance and commercialization.
Patrick Kurnia
B.Eng (Mech) • M.Eng (Med) • PGCert (Law)
Founder Profile
Patrick attended the University of Auckland where he attained Master of Bio/Medical Engineering degree with distinction, building on a Bachelor’s foundation in Mechanical Engineering. He's currently pursuing Postgraduate in Law specializing in Intellectual Property (IP) and Trademark (TM) Practices, combining technical expertise with regulatory and legal insight.
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