“We are a passionate team of “8” medical device professionals driven by the purpose to contribute to human welfare, by fostering medical device innovations that help in the prevention, diagnosis, or treatment of human ailments.

Naresh Kumar Pagidimarry
(Co-Founder & MD, 8C Healthcare)

Every year, a considerable number of innovative medical technologies are developed to meet the increasing demand for delivering high-quality healthcare services across the board. In general, a new medical device development and commercialization process can take anywhere from 3 to 8 years depending on the type of product being developed and investigated. Focused on the advancement of medical technology from ‘Concept to Clinical Use’, a company called 8C Healthcare emerged in 2010 to establish itself as a trusted strategic partner in the MedTech community.

8C Healthcare is an exclusive Medical Device Research Organization based in Hyderabad, India that provides Comprehensive Clinical Research & Development, Regulatory and Quality Management services for global medical device manufacturers by assuring compliance with medical device standards and regulations in India and Worldwide.

8C Healthcare is founded by a group of self-motivated and like-minded ‘8 Capable’ Biomedical Engineers (Mr. Naresh Kumar Pagidimarry, Mr. Sravan Kumar Manchikanti, Vikram Singh Bhatnagar, Mr. Anil Kumar Pegallapati, Mr. Vivek Palepu, Mr. Rizwan Ahmed, Mr. Koti Reddy Vanga and Mr. Anant Palepu) driven by the purpose to contribute to human welfare, by fostering medical device innovations that help in the prevention, diagnosis, or treatment of human ailments.

COMPANY’S MOTTO

“Your Success is our Future”

“Health is Wealth”

“Together, we make it happen”

“HOW FAR ARE WE STRIVING TO SAVE ONE LIFE?”

MEET THE LEADER

Naresh Kumar Pagidimarry

Naresh Kumar Pagidimarry is a Biomedical Engineer turned entrepreneur with over 18 years of experience working in India and USA on Medical Device Product Life Cycle management including Identifying unmet clinical needs, Ideation / Proof of Concept through design, development, testing, design verification & validation, manufacturing, pre-clinical & clinical research management, global regulatory and quality processes. Prior to starting 8C Healthcare, he worked in regulatory and clinical research positions at Cardiac Concepts, Inc. (Now Zoll Medical), Terumo Heart and St. Jude Medical USA.

He is deeply passionate about MedTech innovations and translating new medical device concepts into market-ready products which could help people to live a healthy life. His specialities are Medical Device Product Development, Clinical & Therapy Development, and Global Regulatory Strategy.

Naresh is a leader of consummate personality who fosters transformational learning and personal enrichment in the minds of every employee working in the organisation. Naresh’s principles, values, and ideology make 8C Healthcare a distinctively placed organisation.

As the Managing Director of the organisation, Naresh develops and executes the company’s business strategies, establishes the company’s policies and legal guidelines, oversees the company’s financial performance, and builds long-term and trusting relationships with employees, partners, and stakeholders.

MEDICAL DEVICE CLINICAL RESEARCH & DEVELOPMENT SERVICES

When it comes to high-quality integrated clinical research management, 8C Healthcare is the first name that comes to the minds of almost every MedTech company. 8C Healthcare, over the years, has established itself as a foremost company offering top-notch clinical research management services to the clients who intend to conduct clinical studies for innovative medical devices globally in compliance with ISO14155, Good Clinical Practices (GCP, an international ethical & scientific quality standard for the monitoring, performance, design, auditing, recording, analysis, and reporting of clinical trials).

Vikram Singh Bhatnagar | 8C HEALTHCARE — Vikram Singh Bhatnagar

“8C Healthcare partners with medical device start-ups and clinical investigators in developing the clinical strategies for the evaluation of safety and efficacy of the investigational device,” mentions Vikram Singh, Co-Founder & Head – Clinical Services.

Under clinical research management, the company provides an array of services specific to medical devices. Some of the notable ones include:

Clinical Trial Strategy: 8C Healthcare helps its clients devise clinical strategies. It includes establishing a clinical development process with the most likelihood of substantiating the product and identifying ideal clinical conditions.

Clinical Trial Protocol Design and Development: Any client investigation starts with the development of a clinical protocol. The protocol is basically a document that describes the objective, methodology, statistical considerations, design, and other requisite information. 8C Healthcare helps with protocol design and development that are in compliance with regulatory requirements.

Case Record Form (CRF): 8C Healthcare makes sure that a CRF contains all the necessary information like study title & number, investigator’s name, study subject, patient ID, demographic data, concomitant treatment, and side effects, investigator’s signature, and other requisite details.

Clinical Trial Auditing: 8C Healthcare is proficient in conducting Clinical Trial Auditing which is meant to ensure that the data collected and submitted is valid and to verify compliance with regulations including the principles of Good Clinical Practices (GCP).

Clinical Trial Monitoring: Under this service, 8C Healthcare oversees the progress of a clinical trial and ensures that the trial is conducted, recorded, and reported, in compliance with the protocol, GCP and other regulatory requirements.

Investigator-Initiated Studies: 8C Healthcare in partnership with clinical investigators from different specialities support and manages the clinical studies to specific research questions from day-to-day clinical care.

Other services provided under clinical research management are Identification of Clinical Investigators (KOLs) and Sites, Investigators Meeting Preparation, Clinical Trial Document Development, Clinical Trial Data Management, Clinical Trial Report, Clinical Trial Agreement and Budget Negotiation, Clinical Trial Budget Development, Literature Search and Review, Preparation and submission of Journal Articles, List and Maintain Trial Details on ClinicalTrials.gov and Clinical Trial Registry of India (CTRI), and many more to list.

REGULATORY & QUALITY MANAGEMENT SERVICES

Apart from delivering the best clinical research management services, 8C Healthcare provides other high-quality Global Regulatory and Quality Management services as well. Some of them are:

1. Regulatory Affairs

For a medical device manufacturer, securing the regulatory approvals is a key milestone in order to launch the products in global markets. 8C Healthcare is a pioneer in delivering comprehensive global regulatory services to clients in India, Europe, the United States, and Asia Pacific countries. Right from country-specific regulatory assessment, clinical trial notifications, and product registrations, to fervently coordinating with the Regulatory Authorities for regulatory approvals, 8C Healthcare positions itself as a leading medical device regulatory partner.

The main services provided under regulatory affairs management are:

Regulatory Strategy
Legal Authorized Representation
Product Registration and Approval
Global Regulatory Submissions (US, Canada, EU MDR)

2. Quality Management System (QMS)

A medical device quality management system is defined as a structured system that documents the procedures and processes implemented throughout the lifecycle of a medical device. 8C Healthcare establishes a quality management system for medical device manufacturers in specific to product portfolio.

The main services provided under quality management are:

Establish Quality Systems in compliance with FDA QSR 21 CFR 820
Post-Market Surveillance & Vigilance Reporting
Quality Audits and Training Programs

Sravan Kumar Manchikanti | 8C Healthcare — Sravan Kumar Manchikanti

“8C Healthcare has established a worldwide affiliate network of Medical Device and In-vitro Diagnostic device experts across the globe to get the product developed, clinically investigated, secure regulatory approvals and successfully launch in the market,” mentions – Sravan Kumar Manchikanti, RAC, Co-Founder & Head – Regulatory Services.

CLIENT RELATIONSHIPS: A Top Priority

With positive and enduring client relationships, companies make giant strides and achieve infinite success. For the holistic growth of the organisation, 8C Healthcare strongly believes that the future of the company lies in the true success of the clients that it works with i.e., “Clients Success is our Future”. Naresh builds and maintains strong client relationships. 8C Healthcare always strives to exceed the client’s expectations. It provides realistic frameworks to avoid any kind of miscommunication with the clients.

Anil Kumar Pegallapati | 8C Healthcare — Anil Kumar Pegallapati

“We leave no stone unturned to deliver the finest services to our clients and believe in retaining clients by building trust in their minds. It gives me immense pride to share that our clients reengage with us for other future projects as well. We always endeavour to perform the tasks successfully keeping in mind the needs and requirements of the clients,” mentions Anil Kumar Pegallapati, Co-Founder & Head – Quality Services.

THE COMPANY’S VALUES

Not revenue, not profits, it is the company’s values and principles that make an organisation morally strong. Values show a clear picture of a company’s atmosphere, and how an employee is treated. 8C Healthcare follows a set of guiding principles to create synchronicity within employees towards a common objective. Here are the values that the company always adheres to:

Teamwork

To open the door to rapid innovation, foster the culture of thinking outside the box, and promote creative problem solving, 8C Healthcare believes in working together to aim for more and achieve even more. The company is equipped with highly professional people with industry-rich experience who are passionate about delivering the best solutions to clients.

Integrity

8C Healthcare is built on the values of honesty, respect, loyalty, and responsibility to promote better decision-making. As the company has been following the path of integrity, every employee is reliable and trustworthy. The company encourages open communication in the organisation so that no issue goes unnoticed or unaddressed. It also establishes a strong work ethic in the workplace.

Trust

8C Healthcare considers Trust a fundamental building block of the organisation. Building trust enhances teamwork & collaboration, improves organisational alignment, efficiency, engagement & productivity, enhances decision making, and most importantly decreases stress and burnout at 8C Healthcare.

Compassion

8C Healthcare operates with compassion to promote dedication, employee engagement, and loyalty, which eventually benefits the organisation. For 8C Healthcare, creating a compassionate workplace has always been a priority.

Professional Excellence

To develop the flexibility to deal with challenging situations, uncertainty and change, 8C Healthcare promotes a culture of excellence. Employees push through the barriers and emerge victorious when they are in a culture of excellence.

THE VISION AHEAD

8C Healthcare, since its establishment in 2010, has been working tirelessly to provide innovative, strategic Regulatory, Clinical Research, Quality and Authorized Representative services for Global MedTech companies that intend to secure regulatory approvals and/or conduct clinical studies in India and worldwide. It is indeed a trusted business partner in the Medical Device Regulatory Affairs and Clinical Research Management domain for global MedTech companies.

8C Healthcare envisions to carve a niche in the MedTech Industry with the most-competent solutions for its partner companies while delivering on-time results. The company’s vision is to propel innovative, high quality and affordable medical devices into the global markets.

In Naresh’s words, “8C Healthcare, since its establishment, has been on a growth trajectory and I am certain that this will continue assuredly.”