Knowledge insights

Best Practices for Ensuring Quality in Embedded Medical Devices


While enjoying a tremendous growth, the medical device business environment has became very competitive, with very complex products. Even though all medical device manufacturers aim to produce high-quality products, ensuring quality best practices does present some challenges.

The rapid evolvements in software, hardware, and communication technologies are generating dramatic innovations in medical devices development, while creating a great market opportunity for many electronic device manufacturers. But the market pressure and the continuous increasing technology complexity bring additional risk and costs associated with errors and defects. In this context quality issues concern everyone, from manufacturers and regulators to doctors and patients.

Best practices in quality assurance can increase a manufacturer’s earnings, lower costs and risks, and allow them to bring better products to the market.

Acting in a highly regulated environment, the electronic medical devices manufacturers face challenges that are different from developing products in most other industries. Continuous attention to quality standards as well as the use of tools and best practices can help companies meet regulatory standards and mitigate risks.

According to “The Medical Device Market: USA” study embedded software is now the primary source of differentiation for medical devices. Thus, embedded software providers can play a crucial role in helping medical device manufacturers faster develop products that meet quality and safety goals. Embedded software providers can bring some advantages to medical device companies, such as:

  • Faster product development through features that can be added more quickly through software than hardware
  • Under the FDA rules and regulations, embedded software will be proved safe and effective, reducing the time of software quality testing by the manufacturer;
  • Advanced quality testing solutions, addressing quality and speed in a way that is precisely aligned with the business needs of the medical device manufacturer.

It’s time for medical manufacturers to work smarter and reach software quality goals without losing their market shares. To read more on how the right partner for your next embedded software development project can help you meet your business objectives, visit Enea website.

By Enea Services

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