A medical device is a gadget, material, software or an apparatus which can be used alone or in combinations, including the product proposed by the medical device manufacturer to be utilized particularly for diagnostic or potentially for therapeutic purposes. And required for its proper application, planned by the Medical Device manufacturers to be utilized for people. Medical devices differ as per their planned use and indication. For example, medical devices like tongue depressors, medical thermometers and disposable gloves to its advanced devices such as computers which help with the control of medical testing, implants, and prostheses. The design plan of medical device constitutes an important section of the field of biomedical designing.
Purpose of Medical Device Manufacturing
• Diagnosis, counteractive action, observing, treatment, or mitigation of infection.
• Diagnosis, Observing, treatment, easing, or pay for damage or incapacitate.
• The investigation, substitution, or adjustment of the life systems or of a physiological procedure.
• Control of origination, and which does not accomplish its important proposed activity in or on the human body by pharmacological, immunological, or metabolic means.
Medical Device Manufacturing in India
There is the national regulatory body like CDSCO for Indian medical devices and pharmaceuticals, it is the licensing authority. The role of CDSCO is to provide the approval to any new medical device which is in the process to be imported to India. Within CDSCO, Drug Controller General of India (DCGI) is the final authority and controls medical devices and pharmaceuticals. Drug Controller General of India is in charge of endorsement of licenses of particular categories of Drugs such as IV-Fluids, blood and blood products, Vaccines and all medical devices. The Medical device manufacturing process is classified and categorized under the CDSCO guideline.

“Those medical devices fall under Class A are considered low-risk devices, such as thermometers and tongue depressors. Low- to moderate-risk medical devices such as hypodermic needles fall under Class B.Lung ventilators and bone fixation plates medical devices fall under Class C and considered moderate-to high-risk devices class D, high-risk devices are Heart valves and implantable defibrillators.”
The regulatory procedures for medical device manufacturing vary according to their classes. These are importing, registering, licensing and clinical trials in India.
Medical Devices Manufacturing in the US
Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). The USFDA allows Medica device marketing in two different processes. Most common to be 510(k) process and second is Premarket Approval process, in the case of Premarket approval, clinical trials are required
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If You Want Medical Devices Services Consultation For Following.

1. Medical Device Manufacturing
2. CDSCO Registration
3. FDA 510 k clearance
4. Continuous Improvement Program
5. Design Control Requirements
6. QMS Certification Services
7. Manufacturing Plant Layout Design
8. Primary Packaging Consultant
9. CE Marking Consultant
10. Combination Product
11. Medical Device Design And Development
12. Clean Room Design Consultant
13. ISO 13485 Certification
14. ISO 15378 certification
15. Medical Device Process Validation
16. 21 cfr part 820
17. 21 cfr part 210 and 211
18. DMF submission
19. CAPA Management
20. TURNKEY PROJECT CONSULTANT

21. Manufacturing Site Conceptualization