A medical device consultant can provide research, regulatory, communication and product development services, so that you can launch your product in the market with confidence
Launching a medical product involves meeting several regulatory requirements and getting all the licenses and certifications required to prove the safety and efficacy of your device. Irrespective of which country you live in, you need to get approval from your local regulatory body such as the Central Drugs Standard Control Organization (CDSCO) in India.
One of the most important things required for the successful launch of a medical device is to have all the documents and communication required for you to make a compelling case to all buyers and stakeholders. This may involve putting together a set of case studies, a literature review, research reports, and more. Outsourcing these tasks from reputed medical devices consultants can help you save time, while ensuring that you can put out error-free, expert-reviewed content.
With a team of over 100 medical device experts based out in India and abroad. We are a proud firm to offer discrete and dependable regulatory consulting for all aspects of your medical devices. Our team helps you ensure that medical technology products are manufactured in line with the relevant quality systems and standards
Give a call and speak with one of our consultants. We’re sure they’ll be able to help you with whatever challenges you may have related to medical devices.
We are following the CDSCO guidelines as well as recommendations of local officials with regards to hygiene practices, minimizing close contact and group assembly requirements. Every one of our employees has complete capabilities to work remotely with full access to client files and project materials. Due to the nature of our business, we have been remotely interacting with many of our international and local client companies for years, as our IT Department based our operational system on a fully digital platform.
To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) is rolling out a voluntary quality certification scheme for medical devices.
The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread anvd injurious phenomenon in the Indian market.oesn’t exist. Clearly list and describe the services you offer. Also, be sure to showcase a premium service.
We are medical devices certification consultants based in Delhi and we assist our clients worldwide in obtaining the certifications required on medical devices in India on their variety of products. Some of them are Surgical gloves, Glucometers, Blood Pressure Measuring machines, Dialysis Equipments , Blood/Blood Component bags, Syringes, Etc.
Blood pressure monitoring machines
Blood/Blood Component Bags