An Overview: Cardiovascular Medical Device
Heart valves, coronary stents, endovascular grafts, and angioplasty balloon catheters are a few examples of cardiovascular medical devices. The design and manufacturing of advanced implantable cardiovascular medical devices can be challenging and time-consuming. The degree of risk associated with the patient of these devices is higher, hence these devices are subjected to significant review by medical device regulators.
To overcome these and other challenges requires both in-depth knowledge and extensive regulatory experience for cardiovascular device manufacturers. These challenges can be particularly daunting for small and medium-sized businesses, which account for the vast majority of medical device manufacturers.
As per the fortune business insights, the global cardiovascular devices market is projected to grow from $54.08 billion in 2021 to $86.27 billion in 2028 at a CAGR of 6.9% in the forecast period.
Considering the risk associated with these medical devices the team of Operon Strategist assists medical device manufacturers in achieving or maintaining compliance with medical device requirements in major markets around the world. Our expert team thoroughly analyses the technical and clinical aspects of the devices, and classifies the devices as per the classification list given by the regulatory authority.
Cardiovascular medical devices can be broadly classified as interventional devices, cardiac rhythm management devices, circulatory support devices, and vascular surgical devices. Coronary stents are the most common cardiac rhythm control device, followed by pacemakers (external and internal) and defibrillators in the interventional device category.
Regulatory compliance for cardiovascular medical devices:
In India CDSCO (Central Drugs Standard control organization) is responsible for regulating medical devices, drugs, and IVDs. Recently CDSCO issued a clarification on cardiovascular medical devices classification.
Cardiovascular devices are classified into number of classes as per intended use and risk associated with them. Pacemakers and other cardiovascular medical devices now require CDSCO Medical Device Registration. To register the pacemaker or other cardiovascular devices manufacturers need to classify their devices first and then need to submit the list of necessary documents to the respective department. If a manufacturer is not Indian, then he/she needs to appoint IAA Indian authorized agent who represents the manufacturer and carries business in India. For CDSCO registration, manufacturers frequently contact a medical device regulatory consultant, which streamlines and expedites their work.
How do we help cardiovascular medical device manufacturers?
Operon Strategist is a team of highly trained and experienced professionals, we provide assistance in the documentation for device design and development to Cardiovascular medical devices manufacturers. Our in-house regulatory consultancy team will guide you in manufacturing plant layout design, QMS implementation, and documentation for regulatory compliance. Our affordable services and extensive network are beneficial to manufacturers as they grow their businesses.
- We provide turnkey solutions for medical device manufacturers.
- We assist manufacturers with Regulatory compliance
- We provide training and implementation as per ISo13485 and 21CFR QSR part 820.
- We create a technical file for the necessary documents.
The majority of individuals in India find it challenging to receive prompt treatment for cardiac illnesses due to high surgical expenses and limited accessibility. Future cardiac disorders among Indians are projected to rise due to poor lifestyle choices (lack of exercise, increased fast food consumption, smoking, etc.) and environmental pressures. The market for manufacturing cardiovascular medical devices having huge opportunities. As a medical device regulatory consultant, we have been working with domestic and foreign clients for more than 12 years, and our list of grateful and delighted clients keeps growing.
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