Services

Services Overview

RCS Global (Access to Global MedTech Consultancy)

RCS Global MedTech provides end‑to‑end regulatory, quality, and project management consulting for Medical Device and IVD manufacturers. 

How can we help you?

With over two decades of hands‑on MedTech experience, we support organizations across the full product lifecycle—from concept and design to global market access and post‑market compliance.

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Quality Management System (QMS) Consulting

We enable seamless access to global markets by managing regulatory submissions and approvals across multiple regions.

Key Services

  1. EU MDR (2017/745) & IVDR (2017/746) compliance
  2. Indian MDR 2017 – Manufacturing & Import Licensing (Class A–D)
  3. Global registrations: EU, US FDA, APAC, ANVISA, TGA, Health Canada
  4. Technical Documentation (Class I to III, including implantable & combination devices)
  5. Labelling and IFU compliance
Global Regulatory Affairs & Product Registration

We enable seamless access to global markets by managing regulatory submissions and approvals across multiple regions.

Key Services

  1. EU MDR (2017/745) & IVDR (2017/746) compliance
  2. Indian MDR 2017 – Manufacturing & Import Licensing (Class A–D)
  3. Global registrations: EU, US FDA, APAC, ANVISA, TGA, Health Canada
  4. Technical Documentation (Class I to III, including implantable & combination devices)
  5. Labelling and IFU compliance

Risk Management & Product Safety

We help manufacturers systematically identify, evaluate, and control product risks throughout the lifecycle.

Key Services

  1. Risk Management as per ISO 14971:2019
  2. Risk files for design, process, and post‑market stages
  3. Integration of risk management with QMS and clinical evaluation
  4. Biocompatibility strategy (ISO 10993)
  5. Sterilization compliance (ISO 11135, ISO 11137)
Design Control & Product Development Support

We support structured design and development processes aligned with global regulatory expectations.

Key Services

  1. Design control documentation and implementation
  2. Design & process validation
  3. Change management and design transfer
  4. Software as a Medical Device (SaMD) compliance support
  5. New product development and global product launch readiness

Clinical Evaluation & Post‑Market Surveillance

We provide comprehensive clinical and post‑market strategies to meet MDR and IVDR requirements.

Key Services

  1. Clinical Evaluation Reports (CER)
  2. Post‑Market Surveillance (PMS) plans and reports
  3. PMCF, PSUR, and SSCP preparation
  4. Regulatory reporting and vigilance support

Training & Capability Building

We empower teams through practical, industry‑focused training programs.

Key Services

  1. ISO 13485, ISO 14971, MDR & IVDR training
  2. Internal Auditor training
  3. Train‑the‑Trainer programs
  4. Lean Six Sigma & DMAIC problem‑solving
  5. Regulatory awareness and compliance workshops

Turnkey Project Management & Cleanroom Solutions

We manage MedTech infrastructure and compliance projects from concept to execution.

Key Services

  1. Greenfield & brownfield project management
  2. ISO 14644 cleanroom compliance (ISO 5 to ISO 8)
  3. HVAC and environmental monitoring solutions
  4. Validation and documentation support

Value to Clients

  1. A compliant, audit‑ready QMS that improves operational efficiency and supports sustainable regulatory compliance.
  2. Reduced time‑to‑market and minimized regulatory risk through accurate, complete, and strategic submissions.
  3. Enhanced patient safety, regulatory acceptance, and reduced product liability.
  4. Robust, compliant product development with fewer redesigns and regulatory delays.
  5. Sustained market approval and continuous compliance throughout the product lifecycle.
  6. Competent internal teams capable of maintaining compliance independently.
  7. On‑time, compliant project execution with optimized cost and operational readiness.

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