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Listing ID:216905
Title:Medical device Turnkey Project Consultant
Description:Operon Strategist is a Leading Certification & regulatory consultancy for medical devices & primary packaging manufacturers. Based in Pune, India, Operon Strategist has a global presence with an international client base. Medical device manufacturers looking to Build up new manufacturing unit can avail our medical turnkey project services. Clients can avail the complete package of medical device turnkey services or it can be customized to meet the immediate requirements of the client. We provide a complete medical device turnkey services including layout design, clean room Design consultant , process validation, developing quality system, documentation, training & implementation. We Provide Medical Device Turnkey project services includes Following: Plant layout & design services plant layout & design is an important element while setting up a manufacturing unit. While design the plant/facility layout, due consideration has to be given to the regulatory requirements, in particular the cGMP requirements. The plant layout thus designed has to ensure a smooth flow of man & material through the plant. Clean Room Design Consultant services Many medical devices are manufactured & supplied sterile. Some medical devices are sold unsterile but require a low bio-burden. Clean room helps in establishing & maintaining an environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors. Medical Devices Process Validation services Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages. Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation.
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Owner Name:operon strategist
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