Healthcare - Product Development & Manufacturing
Because better products mean better patient care
Customers with innovative and sophisticated products have made Healthcare one of our leading sectors at Enercon for three key reasons:
- Depth and breadth of experience designing and manufacturing medical products
We have a wealth of experience in a range of healthcare areas, from early symptom diagnostics to therapeutic solutions for some of the most demanding medical challenges. Our application experience includes medical devices and instrumentation, pharmaceutical/drug delivery systems, as well as life sciences research. Our manufacturing software systems provide an industry-leading level of traceability and eDHR documentation.
- Expertise in managing the regulatory process
We understand medical industry regulatory standards. Our Product Development services include stringent quality controls across the Total Product Life Cycle, including requirements definition and development, technical design reviews, design verification, risk management, and analysis. Our proven processes comply with the FDA’s Quality Systems Regulation 21 CFR Part 820, as well as ISO 13485:2003. We create and maintain compliant DHF and DMR packages to support our customer FDA submissions. We are also have accreditation in Japan as a Foreign Medical Device manufacturer.
- Innovative engineering solutions
Wherever you are in the product development process, from early concepts or any step along the way, we can design and manufacture the complex technologies required for a wide range of medical products, including imaging, optics, measurement, and analysis of critical healthcare functions.
Our complete Product Development, Manufacturing and Value-Added services, from direct distribution to inventory management to warranty support, provide healthcare companies with the support that is essential to bringing innovative new products to market quickly and cost-effectively. That's good news not only for patients, but also your bottom line.