The global scenario for regulatory compliance and certifications for medical devices is undergoing an exponential change. It is being fuelled by the increasing usage of automation technologies by manufacturers in this domain. Today, if a manufacturer wants to sells its products in USA , UK and European countries, they require EU, UK and US FDA certifications. In an extended range of cases, it has been observed that manufacturers are unable to distribute their products in foreign markets due to the lack of information regarding the regulatory compliance.
Med Devices Lifesciences was founded to address these challenges in the market. Being a company having offices in India, it has helped many native manufacturers acquire global certifications so that they can sell their products in all foreign markets.
According to one of the Founder of the company, clients are facing two primary challenges in terms of global distribution of products. First is the lack of understanding of all the compliance guidelines because of which companies are unable to get approvals from certification bodies. Secondly, the cost involvements related to certification and testing of medical devices, which are now higher than they were before.
Med Devices Lifesciences is having it’s group company as the government approved testing lab, established in the Mohali industrial area. They are able to provide testing services to their clients as per various international standards.
In case there are non-conformities found in their products during testing, they can help rectifying them and help them and their product to comply for the global market”, mentioned Nidesh Khatri, CEO, Med Devices Lifesciences.
Growth Story
The company was established in 2008, and for the last 17 years it has been providing impeccable regulatory compliance services to companies in the medical devices industry. Initially, Med Devices Lifesciences has built partnerships with several bodies in different countries and helped client get global certifications. Later in 2010, it has established its own testing lab and got it approved by the National Accreditation Board for Laboratories (NABL) especially for electrically operated medical devices. Today, any report that is provided by the company is acceptable globally.
This is one of the primary advantages of availing services from this company. They provide end-to-end testing, certifications and regulatory services to all our clients. There is dedicated team of reviewers, auditors, and testing engineers who are very well versed with their respective line of work.
“We also help our clients (through training and GAP audits to to comply and prepared and meet documentation requirements in terms of medical devices’s certification”, stated Nidesh.
Until now, Med Devices Lifesciences has established five native offices in Delhi, Ahmedabad, Chennai, Mumbai, and Mohali. It has three overseas offices situated in the UK, the US, and the Netherlands. From the overseas offices, it has been providing many foreign medical devices companies to get the EU, UK and the US FDA certifications, and has created a name for it globally. The primary aim of the company is to facilitate a quick entry of clients into their desired markets.
This is the reason why the company has transformed itself over time into a one stop solution for all kinds of compliance requirements related to medical devices certification. In the last two decades, the company has gained significant trust and recognition in the market because of organised and honest approach.
The primary aim of the company is to facilitate a quick entry of clients into their desired International Market
Future Endeavours
Looking ahead, the company wants to delve into few other niche areas that include software validation services for medical devices. “Recently updated version of Medical Device Regulations has given more emphasis on software validation due to technology shift during the last decade or so”, concluded Nidesh.
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