Device Design and Development SteriPack has the capabilities to oversee the design and development of medical devices from the initial concept through to serial production. Using systematic approaches, the experts at SteriPack are experienced at delivering design-risk management, a structured concept stage and design robustness, and production optimisation to achieve predictable product outcomes. How SteriPack achieves predictability during product development? By cooperating closely with clients, focusing on product adjustment and optimisation in initial phases of a product’s life, and foreseeing any possible risks before the product reaches production, SteriPack is able to optimise the design and development process. Some of the services provided by SteriPack design & development of medical devices: Product research Product design Risk analysis (Design Failure Mode and Effect Analysis [DFMEA]) Tool build management Optimisation Design control Learn more about device design and development on HS DESIGN website. SteriPack's expertise: design and development of medical devices by SteriPack’s experienced team brings wealth that will support you to create and produce complex and innovative medical device products. You may be interested Medical Devices Sterile Barrier Packing MORE > Medical Devices Regulatory Services MORE > Medical Devices 3D Printing MORE > © 2021 by SteriPackGroup.com CAREERS CONTACT US BLOG PRIVACY POLICY GENERAL TERMS & CONDITIONS

Quality and Microbiological Testing SteriPack Contract Manufacturing offers a variety of functional testing services with custom made testing jigs & equipment, dimensional testing and microbiological testing including bioburden, sterility and endotoxin testing to assure compliance of product safety. SteriPack covers a wide range of testing at ISO 17025 accredited Laboratory assisting with the demands for product and material testing requirements. Accredited microbiological laboratory testing fields: Bioburden ISO 11737-1 Sterility ISO 11737-2 Endotoxin Ph.Eur./ USP Purified water Ph.Eur Environmental/ clean room testing ISO 14644, ISO 14698 (air, surfaces, personnel) Visit SteriPack dedicated laboratory website using this link: MYSTERILAB.COM Quality laboratory testing to meet quality requirements for medical devices: Dimensional control by 2D optical microscopes and measuring devices 3D Dimensional control by CMM coordinate measuring machine 3D external and internal dimensional control by CT scanner X-ray computed tomography Sterile Barrier testing according to 11607-1, 2 (peel off, dye penetration, seal strength, bubble leak, vacuum, accelerated aging, real time aging, transportation simulation tests) Tensile test Torque test SteriPack's expertise: sterile barrier testing, sterility, bioburden and LAL tests. You may be interested Clean room Injection Moulding MORE > Medical Devices Design & Development MORE > Medical Devices Assembly MORE > © 2021 by SteriPackGroup.com CAREERS CONTACT US BLOG PRIVACY POLICY GENERAL TERMS & CONDITIONS