As Turkey Project Consultants, we work on complex technical and guide in planning the medical device manufacturing plant layout which is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum. Medical Device Turnkey Project Consultants 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.
Why Choose Turnkey Project?
Operon Strategist has a team of trained professionals that work according to set standards and constantly upgrading their work techniques that assure meeting customer requirements timely and as per defined quality standards. To serve the diverse requirements of the clients we are the best Turnkey Project Consultant, wherein we assist our customers by offering comprehensive solutions to create Manufacturing Plant Layout Design that suits the client’s requests and requirements in their turnkey project while adhering to industry environment standards, partner product installation standards and customer quality standards. We follow a well-defined work methodology for organized working which leads to zero-errors and higher-efficiency, that assures meeting customer requirements timely and as per defined QMS Certification Standards. We build a long-term relationship with customers based on trust, quality work and on-time service.
The benefits of a turnkey project with us is that customers
- Can characterize the task-extension and results alongside us ahead of time.
- Can define exactly the project scope and results with our expertise.
- Can dedicate the project coordination activity with third parties like draftsmen, structural designers and contractors to us.
This helps customer spare time and reduces costs to a great extent.
All through the project realization (arranging, delicate, development and charging stages) of a turnkey project, the customer can likewise use the skill and the experience of our strategic buying capital goods.
We know the entanglements of the business and guide our customers securely to the turnkey handover of their investment. We also take into account local tender requirements and specifications if so specified.
We Provide Turnkey Project Consulting Services For This Two Sector
Manufacturing Plant Layout 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.
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 medical device regulatory consultants.
We hired Operon Strategist the medical device 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.