• Empowering Medical Innovation with Precision Engineering

Engineering Excellence in MedTech

The medical device industry is rapidly evolving with technological advancements and a focus on high-performance, patient-safe solutions. FVG partners with medical device OEMs to provide innovative and reliable manufacturing solutions for consumables, devices and equipment, including catheters, diagnostic tools, life sciences and 3D-printed healthcare products. With expertise in compliance and advanced manufacturing, we efficiently bring cutting-edge technologies to market while ensuring precision, quality and safety. Whether developing new devices or optimising existing ones, we offer the expertise and support needed to succeed in this competitive, highly regulated industry.

Our Capabilities

Advanced Material Expertise

Biocompatible LSR and medical-grade thermoplastics support high-performance moulding for life-critical healthcare and diagnostic applications.

Co-Development and Prototyping

Rapid, iterative development of medical devices—including catheters, tubing and wearables—supported by close customer collaboration and integration of smart technologies like IoT and remote monitoring.

Precision Manufacturing

Medical-grade thermoplastic and elastomeric moulding, including insert, overmoulding and 2K processes—performed in ISO 14644 Class 7 & 8 cleanrooms with in-house mould design and validation.

Electronics PCBA

Development, validation and production of diagnostic boards with DFMEA and PFMEA methodologies—driving high first-pass yields through layered testing strategies and robust risk mitigation.

Quality Assurance and Validation Experience
Quality Assurance and Validation Expertise

ISO 13485-compliant manufacturing with IOPQ validation experience for products and components up to Class IIb medical device classification.

Integrated Medical Assembly

Assembly of medical devices, diagnostics and life science systems—combining electronics, fluidics and enclosures under ISO-13485 compliance and validated processes.

Our Proven Solutions

Precision Manufacturing for Critical Healthcare Solutions

We support the development and manufacturing of a wide range of medical products across diagnostics and treatment. From diagnostic instruments and point-of-care devices to respiratory solutions, wound care systems and neurological equipment, our expertise ensures precision and reliability at every stage. We also serve specialised segments, including dental capital equipment, medical microscopy and oral care devices—delivering high-quality assemblies that meet clinical standards. With a strong focus on regulatory compliance, patient safety and technological innovation, we help bring critical healthcare products to market efficiently and at scale.

Diagnostics
Point of Care
Respiratory Devices
Wound Care
Neurological Devices
Dental Capital Equipment
Medical Microscopy
Oral Care Devices

Case Study: Ultrasound Scanner

Case Study: Ultrasound Scanner

FVG supported the development of a breakthrough medical device, an IPX67-compliant ultrasound scanner designed for nasogastric tube guidance. Built within a miniaturised enclosure, the system required leakproof sealing, drop resistance, and real-time detection capability with fully integrated firmware and electronics.

Manufacturing Process:

  • Testing and Inspection: Sealing, drop testing, and functional verification protocols aligned with clinical environments.

  • Precision Assembly: Robust assemblies engineered to meet stringent performance and medical durability standards.

  • Full Box Build: End-to-end integration including PCB design, firmware development, and mechanical fabrication.

Prototype units were delivered for clinical trials with precision-built assemblies that met IPX67 durability and functional validation. The device represented a pioneering step in ultrasound technology, positioning it for regulatory approval and eventual market introduction.

Insights

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