Welcome to Meditix Solutions
+91 88844 48072    info@meditixsolutions.com


Compliance solutions for Medical Device companies. Meditix Solutions Private Limited is a technical consultancy company provides support to QMS solution, regulatory advisory & guidance, Risk management support, assists in Clinical Trials, Clinical investigations and evaluation support to various manufacturers in the healthcare industry to ensure their products, processes, systems or services are compliant with national and international regulations and standards.

ISO 13485 : 2016 Certified Consulting Company

We provide expert advice in Quality management system implementation according to ISO 13485: 2016, 21 CFR 820 and MDSAP requirements. We have efficient team with decades of experience in Internal and External audit support. We do have capability to develop entire QMS system for your company and train your team to meet all the requirements.

We provide wide spectrum trainings on ISO, IEC standards, MEDDEV guidelines, MDSAP, 21 CFR 820. We offer a comprehensive range of medical device training courses covering a variety of formats. Courses can be customised to your requirements.The sessions will cover both theoretical and practical knowledge gained from experience.

Our compliance services include support to designers, developers and manufacturers inproduct testing and problem solving.Our compliance services include an end-to-end test life cycle offering involving process, people and tools. We provide test design, execution, and documentation by employing a proven quality program.

We support Clinical Trials according to ISO 14155 requirements. Our clinical experts have decades of experience in conducting medical device clinical trials to Global requirements. We offer custom support depending on your needs such as Literaturebased analysis, Equivalency Demonstration and Post-market study.

We provide support throughout your entire product development cycle to help you navigate the complexities of building a Risk Management File to incorporate risk analysis, hazard analysis, production/post-production device monitoring, and more.

We ease your work by assisting for Europe – MDD &MDR, USFDA – PMA &510(k), Health Canada, Singapore - HSA, Australia – TGA, Brazil – ANVISA, Colombia – INVIMA, India – CDSCO, Japan – PMDA Mexico – COFEPRIS, South Korea – KFDA approvals and other global markets approvals.

We assist you in gaining the required certifications to trade in your target markets

  • PMA for all Class II and III devices.
  • EU Council – CE mark for all Class I, IIa, IIb, and III medical devices
  • TGA – Class I, IIa, IIb and III.
  • HSA – Class A, B, C and D
  • Health Canada – Class I, II, III and IV
  • IMDR – Class A, B, C and D