ELMAS is a leading regulatory affairs consulting company specializing in medical devices and in-vitro diagnostics (IVD) products, with multiple international offices. We offer expedited registration, independent license holding, importing, commercial support services, and business consulting in the BRIC countries (Brazil, Russia, India, and China). Our regulatory experts possess extensive knowledge of each country's regulations and requirements, ensuring seamless product launches in these markets. ELMAS is a vital consulting partner for entering the international market and achieving success in the medical device sector.

Techsol Life Sciences is an integrated clinical development, medical affairs, and post-marketing surveillance business solutions provider to global medical device companies. We specialize in delivering value-focused medtech clinical services that includes regulatory lifecycle management, EU-MDR / IVDR consulting, medical writing, clinical investigations, biometrics, device vigilance, product certification, device labelling, artwork management and conducting different types of post-marketing and real-world evidence studies. Using our deep-domain scientific expertise, we are a trusted partner for medical device sponsors to navigate through complex regulatory requirements, gather clinical and safety evidence, launch new products, and proactively perform post-market surveillance reporting across different classes of medical devices.

Please write to us at info@techsollifesciences.com or visit

Freyr Solutions is a global leader in Regulatory solutions, dedicated to providing comprehensive, end-to-end services for the life sciences industry. Freyr is at the forefront of Medical Device Regulatory Affairs, offering specialized expertise in device classification, registration, and compliance across global markets. Freyr’s services cover all aspects of medical device lifecycle regulations, including market authorization, UDI implementation, QMS compliance with ISO 13485, clinical evaluation report preparation, and post-market surveillance. Freyr caters to a diverse range of device classifications, from low to high-risk categories, ensuring adherence to the latest global standards and country-specific requirements.

With over 14 years of specialized experience, 2100+ in-house experts, and a network of 850+ in-country affiliates across 120+ countries, Freyr stands as the trusted partner for life sciences companies navigating the complexities of global Regulatory landscapes. Freyr’s commitment to excellence is reflected in its growing portfolio of 1550+ global customers and presence in 20+ countries worldwide.

Freyr’s robust infrastructure is ISO 9001 & ISO 27001 Certified, ensuring the highest standards of quality and information security.

For more than 45 years, LDRA has developed and driven the market for software that automates code analysis and software testing for safety-, mission-, security-, and business-critical markets. Working with clients to achieve early error identification and full compliance with industry standards, LDRA traces requirements through static and dynamic analysis to unit testing and verification for a wide variety of hardware and software platforms. Boasting a worldwide presence, LDRA is headquartered in the United Kingdom with associated companies in the United States, Germany, and India, coupled with an extensive distributor network.

MRIDA is the medical devices testing and training division of Palamur Biosciences - a leading PreClincal Contract Research Organisation (CRO) located near to Hyderabad.

We offer extensive pre-clinical testing services across cardiovascular, gastrointestinal, integumentary, skeletal, genitourinary, ophthalmic, neurological, and dental, using various animal models, including large animals such as Dogs, Pigs, monkeys, and sheep/goat. Our AAALAC accreditation and OECD GLP certification ensure the highest standards of animal care and scientific integrity.

Our expert team supports the development and approval of new medical devices, ensuring safety and efficacy for human use. Our state-of-the-art facilities feature advanced infrastructure and cutting-edge equipment, including:

• Philips Azurion Cath-Lab for cardiovascular procedures
• Ventilator/Physiological Monitor for real-time vital monitoring
• Advanced imaging technologies like IVUS and OCT
• Echocardiography and Cardiac Doppler systems
• Cardiopulmonary Bypass system and Defibrillator
• Scanning Electron Microscope (SEM) for high-resolution imaging
• Endoscopy Suite for minimally invasive procedures

MRIDA's comprehensive services, advanced technological capabilities, and commitment to excellence make us a leader in preclinical testing for medical devices. We strive to support the medical community by providing reliable data that accelerates the development of safe and effective medical innovations.

Operon Strategist is a team of technical experts and professionals in medical device regulatory consulting. We are the leading consultancy in the industry, providing specialized expertise in turnkey solutions, system implementation, training, licensing, regulatory approvals, and certifications.

We provide turnkey services right from product design and development, and manufacturing unit design up to achieving regulatory approvals. We assist in getting approvals and licenses from regulatory bodies: USFDA 510k, CE, UKCA, Saudi (SFDA) and CDSCO.

Our technical team is competent in providing timely execution of project deliverables and assuring confidentiality. We keep ourselves up to date with current market scenarios and the latest guidelines. Our commitment to cost-effectiveness, timely delivery and high quality standards has established us as a trusted partner for many companies.

We are committed to delivering outstanding services at affordable prices, utilizing cutting-edge technologies. Our goal is to develop long-term relationships with our clients based on trust, quality of work, and timely service. Depending on the needs of our clients, we tailor and customize our services.

We aim to emerge as a global player in medical device regulatory and turnkey project consulting. As a company, we strive to be the best and to be committed to our work.

Astakenis is an IT firm, a pioneering provider of cutting-edge, cloud-based Quality Management (QMS) Software solutions specifically designed for the demanding requirements of the pharmaceutical and Contract Research Organization (CRO) sector.

At Astakenis, they understand the critical importance of ensuring stringent quality standards and regulatory compliance within the pharmaceutical and CRO industry. Their mission is to empower the companies with innovative technology that streamlines and enhances their quality management processes, enabling them to achieve unparalleled efficiency, compliance, and excellence in their operations.

Astakenis Cloud-based software / database have been validated by several international authorities, including the USFDA, EMA, MHRA, Health Canada, DCGI, and others, and meet regulatory requirements such as HIPAA, ICH, GxP, 21 CFR Part 11, Annex 11, GDPR, and others.

Please write to them at info@astakenis.com

Clinevo Technologies is an IT firm that provides regulatory compliant and user-friendly cloud-based Software Solutions for Drug Safety / Pharmacovigilance and Clinical Trials to over 200+ Pharma / CROs.

Clinevo Technologies help companies perform Pharmacovigilance in a highly efficient and cost-effective manner through their Integrated Drug Safety Platform with Database, AS2 gateway, Signal detection, Case Intake, Literature management and SDEA agreements capabilities.

Clinevo Cloud-based software / databases have been validated by several international authorities, including the USFDA, EMA, MHRA, Health Canada, DCGI, and others, and meet regulatory requirements such as HIPAA, ICH, GxP, 21 CFR Part 11, Annex 11, GDPR, and others.

Please write to info@clinevotech.com

Maven Profcon Services LLP is a regulatory consulting organization specializing in medical and IVD devices. With over 8 years of experience, we have worked with more than 300 prestigious organizations across various medical device sectors globally. Our expertise encompasses consultation, documentation, implementation, training, testing, certification, and validation.

As a leading consultancy with a strength of 80 in-house consultants with expertise in the field of medical and in vitro diagnostic (IVD) device regulation, we provide a comprehensive range of regulatory services to assist manufacturers in meeting their compliance objectives, including but not limited to CE marking, USFDA approvals, UKCA, Indian MDR compliances, MDSAP, ISO 13485, Gap analysis of documentation, Clinical evaluations, Human factors engineering, PMCF studies, etc.

Our expertise ensures that manufacturers can efficiently interpret and comply with regulatory demands, thereby streamlining the process of bringing their products to market.

Auriga Research Private Limited is a leading Testing, Inspection, and Certification Organization with 39 years of specialized experience in the industry. As a service provider, Auriga offers end-to-end support, functioning as a one-stop solution with six state-of-the-art laboratories, supported by a team of over 950 professionals. Auriga is dedicated to delivering excellence in the medical device industry, with a strong focus on analytical and clinical research, ensuring rigorous adherence to the highest standards of quality and compliance.

Our laboratories are CDSCO registered and approved for Form MD-40 Medical Device Testing, we are equipped to test and evaluate various classes of medical devices, including Class A, B, and C devices such as catheters, hypodermic needles, surgical dressings, and orthopedic implants, using advanced technologies and approved methods.Our laboratories are accredited by CDSCO, NABL (ISO 17025), USFDA, BIS, WHO, and other global authorities, ensuring the highest standards of safety and compliance.

We offer clinical trial solutions, including study design, protocol development, site management, and regulatory compliance. Our expertise covers everything from study synopsis creation to post-market surveillance, ensuring that medical devices meet stringent regulatory standards throughout their lifecycle. Auriga Research is your trusted partner in navigating complex regulatory landscapes, bringing safe and effective medical devices to market with excellence and reliability.

Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, maintaining the highest levels of data integrity and security. The technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services that include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups.