Gold Partners

Elmas Group is the expert organization in Russia that provides full range of advisory, certification and laboratory testing services in accordance with national and international requirements. The Availability of our testing laboratories including ILAC accredited laboratories, National certification bodies accredited by the Federal Accreditation Service. Our own production of unique non-standard laboratory equipment subsidiary and partnerships with international consulting companies enable us to provide full scope of services aimed to confirm quality and conformity to applicable regulations. We have vast experience in registration of medical devices in Russia with possible cooperation acting as your partner and official local representative of manufacturers all over the world.

TÜV SÜD is the trusted partner of choice for quality, safety, security & sustainability solutions for over 150 years globally. Headquartered in Munich, Germany and with a global presence across 1000 locations, we have been catering to diverse industries in India through our testing, certification, inspection advisory & training solutions for over 28 years.

The company caters to a client base of over 10,000 companies across a wide range of sectors that include automotive, plant engineering, environmental technology, food safety, textile & leather, hardgoods (toy testing, jewellery, food contact material, etc), healthcare, infrastructure consultancy and technical & non-technical skill development training.

TÜV SÜD’s team of specialists partner with clients to enhance their competitive strengths and provide them with solutions based on reliability, safety, quality, environmental protection as well as cost effectiveness.

Healthcare and Medical Devices

With the healthcare and medical devices sector undergoing rapid changes driven by several trends and challenges, TÜV SÜD’s global team of experts, engineers and medical doctors are well positioned to help the sector navigate through these evolving times. TÜV SÜD has been providing certification and testing services for manufacturers and suppliers of medical devices and in vitro diagnostics, which is facilitated by our in-depth market knowledge and changing industry regulations. Our global team of experts further help in providing assessments that cover the complete lifecycle of your products.

Learn more: www.tuvsud.com/en-in

Contact us:info.in@tuvsud.com

Techsol Life Sciences is an integrated clinical development, medical affairs and post-marketing surveillance business solutions provider to global biopharmaceutical, medical device, food, and nutraceuticals companies. With our commitment to bringing novel treatments and therapies faster to market, we deliver regulatory compliant clinical research services, GxP technology consulting solutions in combination with our unified SaaS platforms. Using our deep-domain scientific expertise and technology innovation, we help sponsors to reduce time-to market, save costs, and realize maximum value, across pharmaceutical and medical device business functions through insights-driven clinical research, compliance oversight, digitalization and GxP process automation.

To know more about the Techsol Life Sciences , please visit https://www.techsollifesciences.com/ or write to us at info@techsollifesciences.com

Silver Partner

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.

Exhibit Partners

Adgyl Lifesciences is a leading Contract Research Organization with over 30 years of GLP experience. We are AAALAC accredited and USFDA inspected. We have serviced over 600 biotech clients across the world. We are the only company from India to have completed over 35,000 GLP studies. Adgyl Lifesciences has an outstanding team of scientists that includes 8 DABTs and 6 ERTs. We have one of the largest private vivarium in South Asia with over 120 animal rooms. Adgyl is your one stop solution for Medical Devices testing with an extensive range of species including Mice, Rat, Rabbit, Beagle dogs, Mini Pigs, Pigs.

List of Biocompatibility Studies at Adgyl Lifesciences:

  • Cytotoxicity - ISO10993-5
  • Irritation - ISO10993-23
  • Sensitization - ISO10993-10
  • Systemic toxicity - ISO10993-11
  • Dual Route Repeat Dose Toxicity - ISO10993-11
  • Material mediated Pyrogenicity - ISO10993-11
  • Genotoxicity - ISO10993-3
  • Hemocompatibility - ISO10993-4
  • Implantation - ISO10993-6
  • Ocular biocompatibility - ISO9394

Connect with us at bd@advinus.com for more details

Trustin Analytical Solutions Pvt. Ltd. is a NABL and CDSCO approved medical device Testing laboratory, located in Chennai, Tamil Nadu. Trustin’s team has a combined experience of more than 75 years in the medical device, pharmaceutical, and Life science industries with a sophisticated facility, and NABL, CDSCO, BIS & UNFPA accreditations. Trustin has the capability to perform Microbiology and Mechanical testing on medical devices (Class A to Class D) such as Surgical & Exam Gloves, Blood Bags, Sutures, Implants (Ortho & Dental), Intraocular lenses, Intra Uterine Devices, Catheter & Stent, Cardio system, Syringe & needles, etc.

Trustin is one of the most trusted service providers with a mission to meet the customer requirements of Method validation (Sterility, Bioburden, BET & AET), Accelerated ageing / shelf-life verification, Device Cleaning Validation, Transport & Packaging validation, Clean room validation, ETO Residues and Product batch testing for their product approvals in India, Asia, US, UK, Health Canada & Europe markets. Trustin has handled 250+ customers & 50+ medical devices, maintaining high levels of quality system in place, data integrity, and confidentiality in a timely manner

Reach us @ 9444303174 / 9003624894 / 9884216380.

Share your queries @ customercare@trustingroup.in

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