from the Blog What to Look for in a Medical Device Sub-Contract Manufacturer

BDK is a specialist medical device sub-contract manufacturer, with core skills in the conversion of flexible materials typically coated with an adhesive.

As Europe’s leading converter, our expertise encompasses everything from concept design to end user delivery.

We value each enquiry and will ensure your idea follows a proven process that will lead to timely success.

A Medical Device Sub-Contract Manufacturer Must Have:

A Structured Product Management Process

An effective product management process is key to success. We have project teams that will take your idea and, through positive collaboration, ensure it is developed into innovative components, assembly solutions and final product.

Customers are diverse and unique which is why attention to detail is crucial. By working closely with every client, tailoring solutions to their application requirements and following our proven and structured product management process, BDK have gained a strong reputation in the medical device industry.

Achievement and Maintenance of Quality Standards

We ensure, as a medical device sub-contract manufacturer, to have the correct certified quality management systems in place.

  • ISO 13485 accreditation, a prerequisite for the manufacture of medical devices, is maintained throughout BDKs operations.
  • Additionally,  ISO 9001 accreditation demonstrates our further commitment to maintain a quality driven organisation.
  • BDK is FDA registered a requirement for businesses involved in production of medical devices sold in the USA.
  • Our Class 7 (Class 10,000) clean rooms are bioburden controlled and monitored, and the results are available as required.

Our reputation for outstanding quality reflects our dedication to manufacturing the highest quality products for the medical industry.

Variety of Capabilities and Years of Industry Experience

Our process and industry knowledge, learnt since BDKs inception over 60 years ago, gives us the fundamental capabilities to approach projects with a retained wealth of experience.

Our capabilities are diverse and encompassing, continually evolving to meet our customers unique challenges and requirements. We manufacture over 20 million products every year and stock over 300 materials.

BDK: Specialist Medical Device Sub-Contract Manufacturer

BDK are a confidential partner to many leading healthcare organisations. We supply high quality performance products, specialising in medical device components and innovation healthcare solutions.

Contact us today to find out more and to see what we can do for your project.