Turnkey Project Management
The idea of Turnkey Project Management (TPM) for complex technical and construction projects is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum. Medical device Turnkey project management means that our clients will receive a total turnkey approach to their investment project. Under the project idea, the Project need will be included and completely responsible for all technical coordination tasks with all other trades and client users.
Manufacturing Site Design and Conceptualization
The manufacturing site conceptualization and designing include the designing of the facility that meets the local and international cGMP requirements as expected by various regulators worldwide.
QMS and Certification
Medical Devices are highly regulated products & different countries have a different regulatory approach for market clearance & sale of medical devices. Medical device varies in size, ease of use, safety ranging from simple bandages, surgical instruments to implants.
Manufacturing of Medical Devices requires compliance of regulatory bodies. Regulatory bodies around the world have listed the medical devices that will require guidelines to have adhered for sale in respective countries.
Post Marketing Support
Post-Market Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market. Post-market surveillance is a collection of processes & activities used to monitor the safety & effectiveness of medical devices.
The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants.
We hired Operon consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.