Satori One Click Solutions is a Global Pharma & QA/QC Management, Legal and Regulatory Compliance Consultancy and Advisory Company rendering services to Pharma and other Healthcare product industries/sectors including Pharmaceuticals, API, Medical Devices, Cosmetics, Natural Health Products, Herbal Products, Nutraceuticals, Dietary Supplements, Food Products particularly for USFDA, Health Canada, CDSCO, EMA, MHRA, TGA, and other countries’ regulatory compliance matters. It has been established with the aims & objectives of providing dedicated consultancy services round the clock, globally, across a varied range of service areas, in a cost effective and innovative manner keeping in view the specific needs and benefits of prospective clients through a team of committed professionals with a legacy of experience, knowledge, integrity and sound ethical practices. Satori operates from offices in India, Canada, and the US, maintaining alliances with dedicated teams worldwide to meet clients' demand. The firm ensures high standards and quality of work by continuously monitoring and checking delegated tasks. Satori offers complete outsourcing solutions, helping clients in various aspects of their operations, including identifying manufacturing sites, managing sourcing, ensuring GxP compliances, obtaining regulatory approvals, and conducting production site audits, QA-QC audits, facility audits, and more. The company also provides consulting services that encompass Current Good Manufacturing Practices (cGMP), quality management, Good Laboratory Practice (GLP), validation, qualification, and regulatory agency documentation. Satori specializes in USFDA, Health Canada, EU, CDSCO, EDQM, MHRA, TGA, and other countries' regulatory compliance matters, offering a comprehensive solution to clients in the Indian and international markets.
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Satori Global HealthCare Product Consultancy Services

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Our regulatory team maintains a curated repository of global regulatory requirements, guidance documents, and authority resources to support medical device and IVD regulatory submissions worldwide. This centralized resource helps manufacturers, importers, and distributors stay updated with evolving compliance requirements across major jurisdictions.

How We Track Global Regulatory Requirements

Monitoring regulatory changes across multiple countries can be complex. Our regulatory experts continuously track official regulatory authority portals, guidance documents, standards organizations, and global regulatory frameworks.

At Satori One Click Solutions LLP, we maintain an internal database of regulatory resources used by our consultants during:

  • Medical Device Registration
  • In Vitro Diagnostic (IVD) Registration
  • Regulatory Strategy Development
  • Quality Management System Implementation
  • Market Entry Compliance
  • Global Regulatory Submissions

These resources are regularly reviewed and updated to ensure alignment with the latest regulatory frameworks and guidance documents.

European Union (EU) Regulatory Resources

Key regulatory frameworks governing medical devices and IVDs in Europe:

  • EUDAMED Database – Economic Operators, Devices, and Certificates
  • Notified Bodies (EU MDR / IVDR)
  • EU Medical Device Regulation (EU MDR 2017/745)
  • EU In Vitro Diagnostic Regulation (IVDR 2017/746)
  • Medical Device Coordination Group (MDCG) Guidance Documents
  • MEDDEV Guidance Documents
  • NB-MED Guidance Documents
  • OEIL – Legislative Observatory (EU Legislation Monitoring)
  • European Association of Authorized Representatives (EAAR)
  • Competent Authority Contact Points (EU Member States)
  • Notified Body Operations Group (NBOG) Documents

United States Regulatory Resources

Medical devices in the United States are regulated by the U.S. Food and Drug Administration (FDA).

Important regulatory resources include:

  • US Code of Federal Regulations (CFR) Search Tool
  • FDA 21 CFR Database
  • FDA Guidance Document Database
  • FDA CDRH Medical Device Databases
  • FDA Establishment Registration & Device Listing
  • FDA Premarket Notification (510(k)) Guidance
  • FDA De Novo and PMA Guidance Documents

Canadian Regulatory Resources

Medical devices in Canada are regulated by Health Canada.

Key regulatory resources include:

  • Canadian Medical Device License (MDL) Database
  • Medical Device Establishment License (MDEL)
  • Canadian Medical Device License Application Fees
  • Health Canada Guidance Document GD210
  • Canadian Medical Devices Regulations (CMDR)
  • List of Health Canada Recognized Registrars for ISO 13485

United Kingdom Regulatory Resources

Medical devices in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

Key regulatory resources include:

  • UK Medical Device Regulations 2002
  • MHRA Medical Device Registration Portal
  • UK Responsible Person Requirements
  • UKCA Marking Guidance
  • MHRA Guidance Documents for Industry

Global Regulatory Frameworks

International regulatory harmonization initiatives support global medical device compliance.

Important resources include:

  • International Medical Device Regulators Forum (IMDRF)
  • Medical Device Single Audit Program (MDSAP)
  • Global Harmonization Task Force (GHTF) legacy documents
  • International Council for Harmonisation (ICH) guidance documents

International Standards & Testing Resources

Global standards organizations and testing laboratories supporting medical device compliance:

  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Eurofins Medical Device Testing
  • Estonian Centre for Standardisation
  • IEC 60601 Medical Electrical Equipment Standards

How Satori Supports Global Regulatory Compliance

Satori One Click Solutions LLP provides regulatory consulting and market entry support for medical device and healthcare companies globally.

Our services include:

  • Global Regulatory Strategy
  • FDA 510(k), De Novo, and PMA Submissions
  • EU MDR / IVDR CE Marking
  • CDSCO Medical Device Registration (India)
  • Health Canada MDL / MDEL Licensing
  • MHRA UKCA Compliance
  • ISO 13485 QMS Implementation
  • Clinical Evaluation & Risk Management
  • Regulatory Intelligence & Compliance Monitoring

If you need regulatory support for US FDA, EU MDR, UK MHRA, Health Canada, or CDSCO approvals, our regulatory experts can assist with end-to-end compliance and submissions.

Website: www.satoriocs.com