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Medical Device Product Recall Management

HM Product Solutions provides OEM medical device recall management services both globally and locally. Centrally located in North America, HM Product Solutions offers a high level of process management prowess that is based on lean manufacturing techniques and a proprietary software program for product recall management that provides seamless integration into client’s tracking systems.

Managing product recalls and the associated risks in the medical device recall marketplace, has evolved into a very detailed and laborious task. Keeping track of differing regional and national requirements can easily result in a complex set of rules that can, at times, be quite contradictory or confusing. Working with a partner that has years of experience meeting US and international requirements is a value-add that allow companies to focus on their core competence and delegate necessary, but peripheral tasks to a competent service partner.

Medical device product recall management is a process that typically incorporates relevant ISO prescribed practices. HM Product Solutions is ISO 13485 Certified. This certification applies primarily to activities performed in highly regulated markets that require high quality standards and documentation tracking. Compliance means an outsource partner employs a more efficient process to conduct business in the US and foreign countries where medical devices may be installed. Certification therefore gives partnering OEMs the assurance that the work they outsource will be completed using industry compliant systems and practices.

HM Product Solutions is an award winning supplier in medical device supply management and Field Modification Instruction (FMI) kits. Their supply chain management professionals are experts in all services such as: new medical device implementation instruction distribution, medical device warranty recall services, medical device sub-assembly / full assembly services and medical device end-of-life notification services. HM understands the challenges that arise and meets those challenges head-on with experience and versatile product recall management solutions.

Simplifying medical device procurement and product recall management for OEMs worldwide, HM offers single-source supply chain management services for all industries and international client’s locations as their expertise doesn’t stop on American soil. They also offer multi-lingual document translation to support FMI kits and medical product recalls.

National and international medical device regulations can be difficult to comprehend. When transparency in the medical device product recall management process is paramount and you require these services, HM Product Solutions is well versed in medical device import and export regulations and compliance. Contact HM Product Solutions today for a complete medical device lifecycle support quote.

product recall management