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Documentation is an element given importance at our company and so we maintain a proper record history of the medical devices, according to the requirements penned in 21 CFR 820.
DHR or device history records of all the medical devices we work on are maintained properly. We comply with the rules of Device Master Record, compiling all the records in one place. To ensure the safety of our records, they are kept in a secure location and electronic back-ups are ensured. These records are made accessible to our customers so they can access them according to their needs.
Complete and comprehensive records of the history of medical devices are kept , inclusive of every element - manufacturing dates, labeling used for our products, primary label of identification records of acceptance , identifications of manufactured devices as well as control numbers. Inclusion of results of testing, the process of device manufacturing and acceptance of incoming material is also ensured in the database records related to the history of the medical device. The documentation is done according to the device master approach, meaning it contains information regarding the formulation of the devices, their composition, specifications of the software’s utilized and the different components of the device.
Data of the production and manufacturing process entails specifications regarding the equipment, environmental specifications, methods of production and the various processes involved in the production of the product. Procedures of assuring quality and the quality assurance equipment which is utilized. Specifications about the labeling and packaging of the products, their maintenance and installation and the methods as well as processes regarding servicing.
We aim to deliver the best products along with the best customer experience to everyone we work with. To guarantee that you have a great experience with us every step of the way, Integra Bio Medical Group will assist you with everything - the design and manufacturing , the storage and shipping of the product.
At integra biomedical group, we believe in being the one stop place for your medical device needs. We will not just handle the whole process regarding the medical device needs of your company, we will handle it exceptionally well. Once you decide to trust us, you will be able to sit back and relax- we will deliver only the best at every step.
Shipping and servicing the manufactured product is one more service that we provide to our customers upon requirement. Once we complete the manufacturing of the product we have facilities that are apt for their storage. Moreover, we can also pack and ship the products to the destination where you want it delivered! We will also work with your company in order to help you develop a repair depot and refurbishment, which will result in happier customers for you.
To facilitate our clients, Integra Biomedical extends them the service of maintaining inventory levels for the purpose of supporting spare parts or items that are consumable.
Refurbishing medical devices, of Class I, Class II and III devices, is done at Integra biomedical. This refurbishing is done while adhering to 21 CFR Part 820. This includes the analysis and documentation of Service reports.
The different devices that we manufacture like cosmetic lasers, dental lasers, diagnostic devices, surgical equipment and more can be easily repaired and refurbished. This can be done with traceability and comprehensive serialization. These devices have the tendency to be redeployed, complete with management of record and DHR.
Trusting Integra Biomedical Group for all your manufacturing and refurbishment needs will undoubtedly be the best decision for the growth of your medical device company. We are the perfect one stop shop for all your medical device needs. Remember, compliance to rules and cost effective product deliverance is our forte!