Sectors

As one of the leading Medtech-CRO we keep in consideration of our clients (Medical Device manufacturers) need and help them to meet the requirements of MDR (Medical Device Regulation) which includes conducting clinical studies to demonstrate the safety and efficacy of their products, obtaining regulatory approval, and ensuring ongoing compliance with MDR regulations. We work closely with medical device manufacturers for various applications for EU/ US and India Approvals for medical devices.

With expert services in Quality Management System Implementation, MDD Transition of existing technical file from MDD to MDR. CE Marking as per MDR 2017/745, Clinical Evaluation and the design and the implement of the Clinical Investigations, PMCF (Post Market Clinical Follow Up)studies and RWE (Real World Evidence)/RWD (Real World Data).

SaMD stands for Software as a Medical Device, which refers to software that is intended to be used for medical purposes without being part of a physical medical device. An example of SaMD is a mobile app that analyzes data from a medical device to help clinicians make diagnostic or treatment decisions.

We work closely with developers to help them meet regulatory requirements, which can be complex and challenging in the case of SaMD due to the dynamic nature of software development. Work in a collaborative environment with the client to get the CE mark for their Digital Healthcare Solutions. Along with a excellent Quality Management System for SaMD (ISO 13485) we also provide services related to cyber security (ISO 27001) and data privacy, which are critical considerations for SaMD products, Software Clinical Evaluations, which are supported by Clinical Evidences.

According to the World Health Organization (WHO), medical devices are equipment whose intended primary mode of action is not immunological, metabolic, or pharmacological in nature and are used in diagnosis, mitigation, therapy, or prevention of disease. From syringes and wheelchairs to cardiac pacemakers and medical imaging technologies (such as MRI, CT and X-ray machines), medical devices can play a range of roles in maintaining and restoring health.

Depending upon the indications for use and risk level of the device The Food and Drug Administration (FDA) has classified the Medical Devices in to 3 major categories I,II,III.

The three classes and the requirements which apply to them are:

Class I General Controls

• With Exemptions
• Without Exemptions

Class II General Controls and Special Controls

• With Exemptions
• Without Exemptions

Class III General Controls and Premarket Approval

According to CDSCO, India medical devices are classified in to four categories (Class A, B, C, and D), (New Medical Device Rules 2018,) where Class A and B present the least risk and Class C and D devices present higher risks to patients

We are an emerging Medtech-CRO work closely with IVD manufacturers to help them bring their products to market by conducting clinical studies and providing support for regulatory approval. We also offer services related to quality assurance, product testing, and post-market surveillance.
We are committed to provide our client best of its kind clinical trial study design, protocol development, clinical trial management, data collection and analysis, regulatory compliance like regulatory dossier compilation and support services, CE Technical File Preparation (as per EU MDR 2017 / 745), US FDA 510K filing ,ISO 13485 Implementation and gap analysis in the existing QMS. Various application for India Approvals for IVDs, Regulatory filings in US/EU/GCC/India/Latin markets, Transition of existing technical file from MDD to MDR. CE Marking as per MDR 2017/745, Gap analysis in the existing documentation and remedial action plan to fill the gap.
Help to identify correct equivalent / predicate device for comparison. Update documents like GSPR, Risk, Clinical, usability etc as per latest standards Help to generate the clinical data and prepare the Clinical Evaluation Report. Identification of EU Rep. EU complaint labeling and UDI set up and other support services. By partnering with us, manufacturers can access specialized expertise and resources that may not be available in-house, allowing them to accelerate the development and commercialization of their products. Additionally, working with us can help ensure that studies are conducted in compliance with regulatory requirements, which can help to mitigate risks and ensure that products are safe and effective for their intended use.

Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. One of the greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance. The use of AI/ML in software is not new; however, the technology has evolved to a point where it can have a significant impact on health care.

Digital health and care refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle. Digital health has the potential to innovate and improve access to care, quality of care, and to increase the overall efficiency of the health sector.

Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among diagnostics, and devices segments. The medical technology industry continues to be one of the most diverse and innovative sectors with a growing global medical device market reaching more than USD 850 Billion by 2030 with a CAGR of 5.5% from 2022 to 2030.

• Early Consulting with the Client
• Regulatory consulting and communication with FDA and Other Regulatory Bodies
• Clinical study planning and execution
• Approval and registration
• Regulatory submission
• Market Access