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Penlon Contract Manufacturing

Contract Manufacturing

Penlon provides small and medium volume contract manufacturing to customers developing medical devices and other highly regulated applications. We specialize in pneumatic, electrical, electronic and software-related anesthesia, ventilation and medication delivery technology.

Penlon offers contract manufacturing services at our UK site and affiliated facilities in India. We encompass every step of ‘concept to product’ from design, prototyping and low-volume trials, to full-scale commercial production.

The medical devices industry and its associated regulations evolve rapidly. Penlon’s robust and integrated Quality Regulatory system, combined with our technical expertise and market understanding, makes us the ideal partner. Working with Penlon provides clients with:

  • 75 years of experience in delivering medical devices designed to the appropriate standards of safety, quality, performance and effectiveness
  • A track record in bringing products to market
  • An FDA registered and European approved manufacturing site with an exceptional compliance record
  • International quality recognition certificates, including US and EU
  • Manufacturing facilities certified to EN ISO 9001, EN ISO 13485, 21 CFR part 820, 13485:CMDR and GMP RDC-16
  • Dialogue with regulatory authorities in more than 90 countries
  • Expertise in the preparation of US FDA 510(k), European CE technical files and other complex global registration dossiers
  • Strong relationships with certified laboratories

For more information please contact +44 1235 547 038 or cmo@penlon.com