Author Archives: operon strategist

Medical device consultancies or the regulatory consultants are highly experienced professionals from healthcare industries. With rapid positive growth  in medical science, the medical device industry is coming up with more and more advanced devices. But launching a new product on the market is not easy. The devices should comply with all the regulatory bodies. ForContinue reading “Know more About Medical Device Regulatory Consultants”

Notified Bodies an overview:  A Notified Body is a third-party organization that has been approved by an EU member state to judge whether manufacturers adhere to the relevant legislation. With such a crucial role, choosing a Notified Body and your partnership’s working relationship are crucial to getting your CE marking. As CE marking medical device consultant, we knowContinue reading “Selection of a Notified Body and Their Process for your new device authority”

If the medical device is manufactured outside of the European Union, the CE marking provides access to European markets for products. Before putting the product on the market in the European Economic Area, the manufacturer shall be required to get and display the CE mark on the product (EEA). This responsibility shifts to the importerContinue reading “ISO 13485 Standard For CE Marking Approval of Medical Devices”

Implantable Medical Device or tissues are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues. Some implants are made from skin, bone or other body tissues.  Others are made from metal, plastic,Continue reading “Implantable Medical Device Manufacturing”

Surgical instruments manufacturing  is done by ONE-piece forging. Surgical instruments are usually made from carbon steel, stainless steel, aluminum, or titanium, and are available in a range of sizes. Surgical instruments are specifically designed tools that are used to assist the health care professionals carry out their specific actions during an operation. For Surgical instruments manufacturing  there areContinue reading “Surgical instruments manufacturing Process”

Disposable Medical device manufacturing or single-use medical devices are medical devices or any medical apparatus or instrument which has the capacity of being used only for once or which has one time use. Disposable devices are used in hospital or healthcare sectors and then after used is been disposed of. The FDA defines that this deviceContinue reading “Disposable Medical Device manufacturing Consultant”

SUGAM is a single window interface to access online services offered by CDSCO. This portal allows users to update and upload data on their website related to license of drugs & medical device manufacturing facilities in India. SUGAM portal is a single window interface. To apply for any form user, you need to register onContinue reading “CDSCO SUGAM Portal “

An Orthopedic Implant is a medical device produced to supplant in the spot of a missing joint or issue that remains to be worked out a harmed bone. Process of orthopaedic implants manufacturing is fundamentally created utilizing treated steel and titanium amalgams for quality and the plastic covering that are done on its goes about as aContinue reading “Orthopaedic Implants Manufacturing”

A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR),Continue reading

Dental implants additionally allude as endosseous implants or fixtures. It is a careful part that is utilized that associates with the bone of the jaw or skull to help a dental prosthesis, for example, a crown, extension, and denture, facial prosthesis or to go about as an orthodontic anchor. What are dental implants? 1.Crown: The tooth-like pieceContinue reading “Dental Implants Manufacturing process”