Elevatia Solutions offers a comprehensive range of services for Regulatory compliance requirements of all classes of medical devices & In Vitro Diagnostic (IVD) device companies.
We have a team of qualified professionals with expertise in governing the registration, import licenses, labelling, as well as the distribution of medical devices and In Vitro Diagnostic (IVD) devices in India.
Registering medical devices in the markets necessitates a tailored approach, involving close collaboration with the relevant Health Agencies for approval.
The typical process for medical device registration involves the following steps:
- Assessing whether a specific device meets the criteria for classification as a medical device.
- Categorizing devices based on the associated risks.
- Identifying the relevant standards and data prerequisites specified by the respective Health Agency.
- Generating the necessary data as mandated by the Agency.
- Compiling a technical file in accordance with the specific requirements of each country.
- Submitting the application and addressing any queries or concerns until approval is obtained.
Our services include:
Medical Device Technical Writing Services:
Technical writing of regulated documents including office documents, company policies, quality management system plans and quality procedures to technical manuals and user guides etc.
Medical Device Staff Augmentation Consulting:
Medical device staff augmentation consulting provides expert Regulatory talent in a consultative and contract capacity to fill your resourcing needs. From the associate to the senior levels, we offer a wide range of key skills and expertise required in the Regulatory space. Whether you require short-term consulting or dedicated resource allocation, we have the flexibility to support your staffing needs.
Medical Device Regulatory Consulting Services:
The Indian medical device market is projected to grow significantly, driving manufacturers and importers to seek effective Regulatory strategies for market entry. Elevatia Solutions offers comprehensive Regulatory Affairs consulting, specializing in medical device registration and more.
Our medical device Regulatory consultants play a pivotal role in streamlining the approval process, collaborating with various Regulatory agencies, and expediting the market entry of medical devices. Moreover, our medical device Regulatory consulting services contribute to development of comprehensive Quality Management Systems (QMS), risk assessments, and the implementation of Corrective and Preventive Actions (CAPAs) & managing Product Recall.
Our medical device Regulatory Consulting is dedicated to ensuring medical device approval. From development through medical device pre-market approval, we ensure full compliance with the applicable regulations.