Medical device manufacturers considering outsourcing of component assembly and kitting must carefully select a partner based on their ability to perform according to rigorous Quality requirements.
Codes and Regulations
Regulatory guidelines for handling, storage and distribution of medical devices are detailed in the Code of Federal Regulations 21 CFR 820 administered by the U.S. Food and Drug Administration.
Proper application of the Code requires planning and oversight by an on-site Quality Assurance department familiar with cGDP procedures. A range of Standard Operating Procedures must be implemented with concerns for personnel, product identification, sanitary standards, production flow, labeling and packaging.
A reputable kitting partner also conforms to international standards set out in ISO 13485 for medical devices. An important element of a comprehensive Quality Management System, ISO 13485 guides the production team in methods that were approved for medical device project design, production and assembly.
Specialized Client Needs
WDSrx clients may also benefit from utilizing integrated Third Party Logistics services for pharmaceutical-grade warehousing and order fulfillment to trading partners, clinical trial participants or specialty distribution channels.
Manufacturers select WDSrx for device assembly and kitting in order to avoid potential mix-ups, damage, deterioration and contamination that are directly related to level of experience. With all of the projects performed by skilled WDSrx personnel in production suites purpose-built for medical devices, manufacturers are assured results that will exceed their expectations.
Medical Device Kitting
Medical Device Kitting is one of the many resourceful videos about services provided by WDSrx. You can watch videos about many services like this one by visiting our YouTube channel.
WDSrx currently has 7 facilities located in Florida (Boca Raton and Pompano Beach), Texas (Sugar Land), New Jersey (Dayton) and Ohio (Lockbourne).
For further information about medical devices and kitting services contact Larry Hotz at firstname.lastname@example.org or call 561-292-0380 x304.