Think about package validation early in product development

Sep 12, 2016 | News

Medical devices are often complicated and expensive machinery that must be treated with care. People’s lives may depend on these devices functioning properly, so why risk damaging the devices with shoddy packaging? Medical device testing is a rigorous and complex process that demands careful planning and attention to detail. Working with experienced professionals for your package validation is one way to ensure a streamlined process without all the stress.

Unfortunately, some medical device manufacturers don’t think about packaging early enough in the product development process. Perhaps that’s because they relegate packaging to second-class citizen status – almost an afterthought after all the sweat and effort expended designing and prototyping the product itself.

It’s important to keep in mind that the purpose of a package is to protect the contents from external interactions that could damage the item. During transit, packages may be bumped, dropped, shaken, stored upside down or sideways.  Even when taking every precaution, there’s simply no predicting what weather your packages will encounter along the way — from sunny and warm to freezing and rainy. Without package validation and thorough testing, you just might be sending your devices to their doom.

Another factor to take into account is how well the packaging is going to age — materials don’t last forever.

MEDIcept provides package validation and comprehensive testing services to take some of the burden off your shoulders. Our state-of-the-art testing facility is equipped with the systems and tools that enable us to provide a wide range of services including test feasibility, design and implementation, protocol development, and complete results interpretation and reporting.

Our specific testing services include:

  • Design verification and validation
  • Usability testing
  • Package/Ship testing
  • Process/equipment qualification
  • Software validation
  • Integration validation
  • IQ/OQ/PQ process validations
  • Product biocompatibility studies
  • Product & accelerated age testing
  • Sterilization validation

MEDIcept can help develop and execute qualification testing and process validation protocols and reports. We can prepare and implement protocols for packaging and aging qualifications, sterilization validations, and biocompatibility testing final reports suitable for regulatory submissions. We can also apply these same skills to testing conducted at your facility on your processing equipment. Call us today for assistance.