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While demand for high-performance medical devices has increased, the number of OEMs capable of building complete assemblies has declined, as a result of a widening skills gap. Many OEMs are suffering severe labor shortages and turning to specialized electronic manufacturing service (EMS) providers to assist with their assemblies and subassemblies. The medical device market is among the most strictly regulated of all industries. With so much hinging on the quality and reliability of these products, medical device manufacturers simply can not afford to release poor performing products.

In the medical device industry, OEMs must identify EMS providers who not only fit their lead time and pricing constraints, but are also capable of exceeding the rigorous standards of the U.S. Food and Drug Administration (FDA). When selecting an EMS provider for your medical device subassembly, it’s important to go into the conversation with a list of basic requirements. To help you get started, here are four key considerations to make when evaluating prospects.

1. Strict Governing Standards

The best EMS providers are experienced in navigating the FDA’s tedious approval process. Reviewing thousands of applications each year, the FDA is one of the strictest regulatory bodies in the world. It’s therefore critical for EMS providers to have a documented framework for all of their internal operations – from initial design mockups to final quality controls.

Examples of the types of documentation that the FDA looks for include:

  • Technical drawings
  • Design history file (DHF)
  • Device master record (DMR)
  • Good documentation practices (GDP)
  • Traceable device history records (DHR)
  • Process validation strategies (IQ, OQ, PQ)
  • QSR and 3rd party verified Quality System – (ISO 9001, AS 9100, ISO 13485)

Robust documentation as well as project management processes are beneficial to the overall business partnership, resulting in prompt communication and minimizing delays in production. A company with established processes and technological investments in forecasting, risk management, production controls, quality assurance, revision management, and root cause analysis, are more likely to both achieve FDA approval, and achieve streamlined operations that simplify the supply chain.

2. Data Driven Procedures

As medical devices have become increasingly complex, the need for OEMs to partner with technologically advanced EMS providers becomes more pressing. Innovative cloud-based software solutions ranging from high tech quality inspection methods to enterprise-grade project management tools allow plant managers to access data pertaining to system defects, test results, equipment efficiency, and resource availability from anywhere in the facility. With such digital technologies, OEMs can maintain complete component traceability and more quickly identify and implement process improvements.

3. Quality Certifications

In the medical device industry, there is no room for error. For a product to get to market, quality certifications aren’t an added bonus but a basic requirement. The foundation of these requirements, is an internationally recognized quality standard (ISO 9001, AS 9100, ISO 13485) that proves a company’s ability to design and manufacture high quality devices and provide associated services. The FDA outlines additional specifications (21 CFR part 820) for quality systems regulations and current good manufacturing processes (CGMP’s), requiring manufacturers to establish process validation systems for their products. To expedite the FDA approval process, OEMs should select EMS providers who are already familiar with these specifications .

4. High Level of Service and Support

Leading EMS providers foster relationships that extend beyond simply assembling parts. They also leverage their manufacturing and supply chain management experience to deliver superior support before and after production. With access to OEM’s bill of materials (BOM), EMS providers can deliver engineering support, design assistance, and expert insights into potential issues that may arise before the manufacturing process even begins – saving time and money on downstream corrections.

 

OEMs in the medical device industry need EMS providers capable of high level partnerships, offering not only the desired manufacturing capabilities, but also industry expertise, quality servicing and dedicated support. Syscom Tech is a certified printed circuit board (PCB) assembly provider with state-of-the-art machinery, industry-proven quality control procedures, and 100% traceability. To learn more about how Syscom Tech could benefit your application, contact us today.

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