About Us
Founded in 2017 in Delhi, TetraMedEx aims to provide complete HR services, including recruitment across various sectors, and help simplify complex global regulations into easy-to-follow documentation. We offer structured training programs for professionals in IVD, medical devices, and pharmaceuticals navigating IVDR, MDR, FDA, and GxP standards.
Our Mission
Translate complex global regulations into audit-ready documentation. TetraMedEx delivers structured, expert-led training paths for IVD, medical device, and pharmaceutical professionals navigating IVDR, MDR, FDA, and GxP frameworks, along with top-notch recruitment services
TretraMedEx Meaning:
“Tetra”: Meaning “four,” it implies structural stability, foundations, and can represent the critical pillars of your platform (e.g., IVD, Devices, Pharma, and Documentation).
“Med”: Instantly identifies your core market of medical devices, diagnostics, and therapeutics.
“Ex”: Signals “Expertise,” “Execution,” or “Excellence” in technical writing and regulatory compliance.
Our Journey
We officially began our journey on December 25, 2017, under the name Bhargava HR Solution, providing specialized recruitment services. As we progressed and gained valuable experience, in the year 2021, we made a significant decision to broaden our scope of operations. We expanded our offerings to include not only recruitment but also ventured into the fields of pharmaceuticals, medical devices, IVD technical documentation, comprehensive plant setup, QMS (Quality Management System) development, and product licensing consulting in India. Additionally, we recognized the importance of knowledge transfer and skill enhancement, which led us to incorporate training services into our portfolio to support our clients better and ensure they are well-equipped to meet industry demands.
FAQ
Does TetraMedEx Offer Recruitment Services Only?
We provide international recruitment and consulting services in HR, IVD Medical Devices, Medical Devices, Laboratories, and Pharmaceuticals. Our expertise goes beyond India, helping businesses worldwide access our specialized knowledge and top solutions. Whether you need skilled talent or strategic advice.
Is the Recruitment Services free for job seekers?
No, job seekers do not need to pay for recruitment services. We help candidates grow in their careers without any costs, connecting skilled professionals with suitable opportunities while maintaining our ethical standards.
What Services Does TetraMedEx Offer?
The 4 Pillars Curriculum Blueprints
Pillar 1: In Vitro Diagnostics (IVD) Pathway
Module 1.1: Navigating EU IVDR 2017/746 Classification Rules (Class A to D).
Module 1.2: Compiling the Scientific Validity & Analytical Performance Report.
Module 1.3: Designing Post-Market Performance Follow-Up (PMPF) Plans.
Module 1.4: Companion Diagnostics (CDx) Regulatory Integration.
Pillar 2: Medical Device Pathway
Module 2.1: ISO 13485:2016 Quality Management System Architecture.
Module 2.2: ISO 14971 Risk Management Files & FMEA Matrix Construction.
Module 2.3: EU MDR Technical Documentation (Annex II & III) Assembly.
Module 2.4: IEC 62304 Software Lifecycle & Cybersecurity Technical Files.
Pillar 3: Pharmaceutical Pathway
Module 3.1: FDA 21 CFR Part 211 cGMP Cleanroom & Production Controls.
Module 3.2: Data Integrity Mastery: Implementing ALCOA+ in the Lab.
Module 3.3: Equipment Qualification Frameworks (IQ / OQ / PQ Execution).
Module 3.4: Process Validation Protocols for Biologics & Small Molecules.
Pillar 4: Technical Documentation Masterclass
Module 4.1: Building the Common Technical Document (CTD) Module 3 (CMC).
Module 4.2: Compiling the Device Master Record (DMR) & History Record (DHR).
Module 4.3: Writing Clinical Evaluation Reports (CER) for High-Risk Devices.
Module 4.4: Change Control Management: Documenting Impact Assessments.
Why Choose TetraMedEx?
Audit-Ready Outcomes: Our courses teach you to write documents that clear FDA, Notified Body, and EMA inspections.
Interactive Traceability Matrices: Learn by building live documents using our downloadable, production-grade templates.
Cross-Functional Expertise: The only platform unifying IVD, device, and drug methodologies under one training umbrella.
Verifiable Credentials: Earn cryptographic, blockchain-verified certificates to prove your regulatory compliance competence.
Ayaan Bhargava