# MedReg Consultancy LLP > MedReg Consultancy is a medical device regulatory consultancy that helps medical device and IVD manufacturers achieve smooth approvals and compliance in global markets. It supports companies across Europe, the USA, India and the UK, covering products from surgical disposables and orthopaedic implants to sutures, diagnostic consumables, and laparoscopic devices. Key facts: - Legal name: Medreg Consultancy LLP (brand: MedReg). Tagline: "Let's Decode The Regulations". - Address: 11th Floor Block C – 1105, 1106 Titanium Business Park, Behind Divya Bhaskar Press, Near Makarba Railway Crossing, Makarba, Ahmedabad, Gujarat, 380051, India. - Phone: +91 88664 61989, +91 63523 88194 (India Standard Time, IST, UTC+05:30). Email: enquiry@medreg.in - Track record: 15+ years of expertise, 550+ projects completed, 300+ satisfied clients, 100+ trainings conducted. - MedReg provides regulatory consulting for CDSCO India, FDA 510(k), and CE Marking, and specialises in Class A, B, C, and D medical devices. - MedReg is a consultancy, not a certification body. It supports clients in obtaining approvals, certificates and licences issued by authorities, Notified Bodies and certification bodies, such as CE marking, UK MDR, ISO 13485:2016 certification, ICMED, MDSAP, US FDA registration and listing, US FDA 510(k), PMA, UL certification, CDSCO licences MD-05, MD-06, MD-09, MD-10, MD-15, Free Sale Certificates, and country registrations. ## Services by market - [All services](https://medreg.in/services/): overview of all markets (Europe, USA, QMS & global, India). - [Europe](https://medreg.in/europe/): CE marking under EU MDR 2017/745 and EU IVDR 2017/746, each with its own page: - [EUDAMED Registration and Compliance](https://medreg.in/europe/eudamed-registration/) - [Unique Device Identification (UDI) Management](https://medreg.in/europe/udi-management/) - [Facility, Product & Directive to Regulation Gap Analysis](https://medreg.in/europe/gap-analysis/) - [Detailed Risk Management](https://medreg.in/europe/detailed-risk-management/) - [European Authorized Representative Services](https://medreg.in/europe/european-authorized-representative/) - [Person Responsible for Regulatory Compliance (PRRC) Services](https://medreg.in/europe/prrc-services/) - [General Safety and Performance Requirements (GSPR) as per Annex I](https://medreg.in/europe/gspr-annex-i/) - [Technical Documentation as per Annex II](https://medreg.in/europe/technical-documentation-annex-ii/) - [Post-Market Surveillance (PMS) as per Annex III](https://medreg.in/europe/post-market-surveillance-annex-iii/) - [Detailed Clinical Evaluation and its documentation](https://medreg.in/europe/clinical-evaluation/) - [Post-Market Clinical Follow-up (PMCF)](https://medreg.in/europe/pmcf/) - [Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP)](https://medreg.in/europe/sscp-and-ssp/) - [Notified body selection, communication and MDR codes](https://medreg.in/europe/notified-body-selection-and-mdr-codes/) - [Risk-Based Device Classification and WET Assessment](https://medreg.in/europe/device-classification-and-wet-assessment/) - [Conformity Assessment Procedures](https://medreg.in/europe/conformity-assessment-procedures/) - [Quality Management System (QMS) Requirements](https://medreg.in/europe/qms-requirements/) - [Cleaning and Disinfection validation](https://medreg.in/europe/cleaning-and-disinfection-validation/) - [Sterilization Validation and Bioburden Testing](https://medreg.in/europe/sterilization-validation-and-bioburden-testing/) - [Biocompatibility evaluation](https://medreg.in/europe/biocompatibility-evaluation/) - [Usability engineering evaluation](https://medreg.in/europe/usability-engineering-evaluation/) - [Technical Documentation Grouping](https://medreg.in/europe/technical-documentation-grouping/) - [Implant Card](https://medreg.in/europe/implant-card/) - [Vigilance Data Collection and Monitoring](https://medreg.in/europe/vigilance-data-collection-and-monitoring/) - [Systems and Procedure Packs](https://medreg.in/europe/systems-and-procedure-packs/) - [USA](https://medreg.in/usa/): US FDA services, each with its own page: - [FDA risk-based classification](https://medreg.in/usa/fda-device-classification/) - [Establishment registration & device listing](https://medreg.in/usa/establishment-registration-device-listing/) - [Premarket Notification / 510(k)](https://medreg.in/usa/510k-premarket-notification/) - [FDA Small Business Determination](https://medreg.in/usa/small-business-determination/) - [Pre-Submission / Q-Submission](https://medreg.in/usa/q-submission-pre-submission/) - [GUDID registration](https://medreg.in/usa/gudid-registration/) - [U.S. Agent services](https://medreg.in/usa/us-agent-services/) - [Medical device labelling (21 CFR 801)](https://medreg.in/usa/medical-device-labelling/) - [QMSR implementation (21 CFR 820)](https://medreg.in/usa/qmsr-implementation/) - [US FDA training](https://medreg.in/usa/fda-regulatory-training/) - [Regulatory reporting (21 CFR 803)](https://medreg.in/usa/regulatory-reporting-mdr/) - [Design control documentation](https://medreg.in/usa/design-control-documentation/) - [Biocompatibility evaluation (ISO 10993)](https://medreg.in/usa/biocompatibility-evaluation/) - [Device Master Record (DMR)](https://medreg.in/usa/device-master-record/) - [Device History Record (DHR)](https://medreg.in/usa/device-history-record/) - [Import and export](https://medreg.in/usa/import-export/) - [Indian Authorized Agent services](https://medreg.in/usa/indian-authorized-agent/) - [Indian manufacturer / supplier evaluation](https://medreg.in/usa/indian-manufacturer-supplier-evaluation/) - [QMS & global](https://medreg.in/other-services/): Quality Management System (ISO 13485) and global regulatory services, each with its own page: - [ISO 13485 certification Quality Management System documentation](https://medreg.in/other-services/iso-13485-qms-documentation/) - [Documentation for Risk Management File](https://medreg.in/other-services/risk-management-file/) - [Preparation of Design and Developments Files](https://medreg.in/other-services/design-and-development-files/) - [Usability Engineering documentation](https://medreg.in/other-services/usability-engineering-documentation/) - [Preparation of Clinical evaluation](https://medreg.in/other-services/clinical-evaluation/) - [Documentation for Post-market surveillance activities](https://medreg.in/other-services/post-market-surveillance-documentation/) - [Annual QMS Maintenance](https://medreg.in/other-services/annual-qms-maintenance/) - [Product development (all categories of medical device)](https://medreg.in/other-services/product-development/) - [MDSAP Gap Analysis and readiness assessment](https://medreg.in/other-services/mdsap-gap-analysis/) - [Implementation of Country-specific Quality management System Requirements](https://medreg.in/other-services/country-specific-qms-requirements/) - [QMS Documentation requirement of Article 10 as per EU MDR 745/2017 & EU IVDR 746/2017](https://medreg.in/other-services/qms-documentation-article-10/) - [Help to identify Notified body](https://medreg.in/other-services/notified-body-identification/) - [Turnkey projects](https://medreg.in/other-services/turnkey-projects/) - [Medical Device QMS and Regulatory Training](https://medreg.in/other-services/qms-and-regulatory-training/) - [India](https://medreg.in/india/): Manufacturing License, Import License, Clinical Trials, Free Sale Certificate, Product Endorsement, Retention of License, Market Standing Certificate, Non-conviction Certificate, Labeling Review, Product Development, Authorized Agent, Wholesale License, Sterilization Process Validation, QMS Documentation, AMC for documentation, Device Master File Preparation, Voluntary Registration, Neutral Code, Internal Audit. - [Training](https://medreg.in/training/): corporate training catalogue and booking form. ## Company - [About MedReg](https://medreg.in/about-us/): who we are, vision, mission and values, leadership, team and gallery. - [Exhibitions & events](https://medreg.in/exhibitions/): where to meet the team; meeting request form. - [Careers](https://medreg.in/careers/): openings and job application form. - [Contact](https://medreg.in/contact-us/): enquiry form, phone, email and map. ## Optional - [Full service descriptions and FAQs (plain text)](https://medreg.in/llms-full.txt) - [MEDICA + COMPAMED 2026, Düsseldorf](https://medreg.in/exhibitions/medica-compamed-2026/): book a 30-minute meeting. - [WHX Dubai 2027](https://medreg.in/exhibitions/whx-dubai-2027/): book a 30-minute meeting. - [Privacy policy](https://medreg.in/privacy-policy/)