Medical Device Manufacturing
The global medtech market is growing fast. Ageing populations, the rise of chronic diseases, and the push for patient-centric care are driving innovation in diagnostic devices, surgical robotics, wearables, and beyond.
Healthcare providers need advanced equipment to deliver life-saving treatments and personalised care to improve patient outcomes. In this dynamic environment, medtech OEMs must navigate stringent regulations, integrate ML-driven software, install cutting-edge sensor technologies, and optimise costs - all while accelerating their time-to-market.
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Launching complex medtech equipment isn’t simple. Turning concepts into robust, real-world devices ready for manufacturing is a challenge. Skills shortages in design, engineering, and prototyping are causing project delays. Supply chains for highly specialised components are hard to manage. OEMs need trusted partners to support them with design, verification, manufacturing and compliance so they can focus on clinical innovation and market expansion.
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The end-to-end cost of bringing a Class III medical device to market in the US can reach $94 million, and to bring a medical device to market can take between 3 to 7 years (source: Science Direct).
Safety, traceability, and reliability aren’t negotiable—they’re mission critical.
At ESCATEC, we work alongside Medtech OEMs from concept through to volume production and post-market support, ensuring your devices meet the strictest global standards. Our DfX approach embeds quality and compliance into your design from the outset, reducing risk, avoiding late-stage failures, and helping you get to market faster.
With ISO 13485-certified cleanrooms, precision manufacturing, and supply chain expertise, we support Class I, II, and III devices - from handheld diagnostics to complex electromechanical surgical systems. As your business scales, our global manufacturing footprint grows with you—delivering cost efficiency without compromising quality.
Industrial Zone 4, 11900 Bayan Lepas, Penang, Malaysia
+60 4 643 2554
Our teams in Europe and Southeast Asia collaborate with you to design and assemble complex medical devices that meet the most rigorous performance, safety and quality requirements. Our end-to-end approach eliminates the error stacking and hand-off delays that can result from multi-partner outsourcing:
Did you know? ESCATEC played a pivotal role during the COVID-’19 pandemic by manufacturing an innovative cold chain monitoring device which helped to safely deliver over 5 billion Pfizer vaccinations in under two years.
We offer contamination-free manufacturing areas for surgical robotics, medical implants, and diagnostic devices.
We provide microelectronics design and assembly solutions for miniature medical devices
We help you meet ISO 13485, FDA, and CE marking standards for global compliance.
We track every material and process to meet strict medical industry standards.
We offer end-to-end assembly, including enclosures, system integration, and packaging.
We identify and mitigate risks to minimise non-conformances, through tailored Corrective and Preventive Action Processes (CAPAs).
We produce high-performance medical devices with exacting accuracy.
We provide full lifecycle management, post-production services, and supply chain efficiency.
ESCATEC specialises in complex electronic and mechatronic design and assembly for the healthcare sector. From cutting-edge ventilators, hearing devices, and pharmaceutical data loggers to advanced drug delivery devices, we have deep expertise in the latest medical innovations launched to market.
Our experience fuels breakthroughs in diagnostics, patient monitoring, and home healthcare - driving better clinical outcomes for patients worldwide.
Industrial Zone 4, 11900 Bayan Lepas, Penang, Malaysia
+60 4 643 2554
We deliver quality at scale, certified to leading international standards:
Industrial Zone 4, 11900 Bayan Lepas, Penang, Malaysia
+60 4 643 2554
Quality Management Systems
Information Security, Cybersecurity & Privacy
Environmental Management Systems
Medical Devices Quality Management Systems
Automotive Quality Management Systems
Industrial Zone 4, 11900 Bayan Lepas, Penang, Malaysia
+60 4 643 2554
In addition, our robust SOPs and processes support compliance with FDA and EU MDR requirements, and our manufacturing practices comply with IPC-A-610 standards for Class II and Class III devices.
Industrial Zone 4, 11900 Bayan Lepas, Penang, Malaysia
+60 4 643 2554
Discover how ESCATEC and Carl Reiner GmBH optimised the Twinstream™ Multi Mode Respirator, enhancing safety and efficiency in medical equipment design.
