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Types of Products we work with..


Main Categories

✿ Medical Devices (MD)
✿ In Vitro Diagnostics (IVD)
✿ Medicinal Products
✿ Companion Diagnostics
✿ Food & Food Supplements
✿ Veterinary Products






Biological Categories

✿ Recombination Products
✿ Monoclonal Antibodies
✿ Vaccines
✿ Blood and Blood components
✿ Cell/Tissue Therapy Products
✿ Xenotransplantation






Other Categories

✿ Combination Products
✿ Borderline Products
✿ Pediatric Drugs
✿ Orphan Drugs
✿ OTC Drugs
✿ Generic Drugs
✿Shortage Drugs
✿ Homeopathic Preparations
✿ Cosmetics
✿ Chemicals and Biocides





Competent Authorities and Medical Agencies that we work with..

✿ It is a comprehensive list of the Governmental bodies, Competent Authorities and Medical Agencies that we work with and help you with registering your products across the Globe.
✿ Needless to mention, if any other countries not listed here, if you are interested and planning to register your products, kindly contact us and we assure to work with them.

✿ European Union (EU) Countries (27)
✿ European Economica Area (EEA) Countries (30)
✿ It includes EU Countries + Iceland, Liechtenstein, Norway
✿ European Free Trade Association (EFTA) Countries (4)
✿ It includes 4 member states Iceland, Liechtenstein, Norway and Switzerland











Asian Countries






Africa






Middle East






North America






South America






Notified Bodies we worked with..

✿ NB: LNE/GMED; Products: IVDD General Devices/IVDR Class A and B
✿ NB: RISE; Product: MDD Class II
✿ NB: Intertek/IMNB; Products: MDD Class I, Im, Iib /MDR Class A and B
✿ NB: Dekra; Products: MDD Class Iib
✿ NB: BSI; Products: MDD Class IIa and IIb
✿ NB: DNV Nemko Safe; Products: MDD Class IIb
✿ NB: UL; Products: IVDD Class I and II





Standaridization Organisations

✿ International Organization for Standardaridization (ISO)
✿ International Electrotechnical Commission (IEC)
✿ The European Commission for Standaridization (CEN)
✿ The European Committee for Electrotechnical Standaridization (CENELAC)
✿ International, European Normalized (EN) and National Standards (Ex: Swedish Standard-SS)
✿ In house standards







Regulations & Standards that we work with..

MDD/MDR

Medical Device Directive 93/42/EEC To Medical Device Regulations 2017/745

IVDD/IVDR

In Vitro Diagnostic Directive 98/79/EC To In Vitro Diagnostic Regulations 2017/746

ISO 13485:2016

Medical Devices - Quality Management System – Requirement for Regulatory purposes

21 CFR 820 QSR

Quality System Regulation

MDSAP

Medical Device Single Audit Program

EN ISO 14971:2012 & 2019

Application of Risk Management to Medical Devices

IEC 60601-1{ed3.1}

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

MEDDEV 2.7/1 Ver 4.0

Clinical Evaluation: Guidelines on Medical Devices

IEC 62366:2015

Application of usability engineering to medical devices

SS:EN 62304:2006

Medical Device Software - Software life-cycle processes

ISO 10993:2018

Biological evaluation of medical devices

ISO 11608:2014

Needle based injection systems for medical use















Platforms we work with..

General IT Skillsets

✿ Microsoft Windows
✿ Unix / Linux
✿ Microsoft Office Package / Share Point
✿ PERL Programming / Adobe Illustrator for Artwork
✿ Adobe Professional, Nuance for PDF, Nitro Pro PDF,
✿ In house developed databases

Specific Software Applications

✿ EDC system (RAVE, Ethical e-Adjudication)
✿ Creation of e-CRF using PheedIT.
✿ Data Management using SAS Programming
✿ MEDRA & ICD-10 medical coding.
✿ Project management tools such as ANTURA, Project Place & Asana
✿ Project Timeline Tool Gnatt

Quality Management System (QMS)

✿ Setting up the whole QMS (ISO 13485:2016)
✿ QMS Plan, Processes, Process Mapping, Implementation & Preparation for Audit
✿ MDSAP Gap Analysis, Implementation and Preparation for Audit
✿ Development of SOPs aiding Regulatory Compliance
✿ Usability Engineering Studies Plan & Report
✿ Risk Management Plan, Analysis & Report & Traceability Matrix
✿ Post Marketing Surveillance Plan & Report





Gap Analysis

✿ Gap Analysis for ISO 13485 – 2003 or 2012 VS 2016
✿ Gap Analysis for MEDDEV 2.7/1 Ver 3.0 VS Ver 4.0
✿ Gap Analysis for Council Directive - MDD 93/42/EEC VS MDR 2017/745
✿ Gap Analysis for Council Directive - IVDD 98/72/EEC VS MDR 2017/745
✿ Gap Analysis for Council Directive – AIMDD 90/385/EEC  VS MDR 2017/745
✿ Gap Analysis for 60601-1 Ed. 3 VS Ed. 3.1
✿ Gap Analysis between any two or multiple quality management systems or SOPs











Internal & External Audits

Internal & External Audits

✿ Have done BSI’s Lead Auditor Training
✿ Have performed Internal Audits
✿ Have been part of several External Audits (As Auditee, Front and Back support)
✿ Have been Audited by Notified Bodies (Unannounced)
✿ Have been Audited by ETL
✿ Create Internal Audit Program, Audit Checklist, Audit Plan, Audit Process, Performing Audit, Audit Report
✿ Certain Segments of Internal Audit, (i-e) Management part to be done by Independent/External Auditors




Clinical Research – Pharmaceuticals & MD

Pharmaceuticals

✿ Strategic Plan
✿ Cinical Trial Application
✿ Ethical Committee Application
✿ Identification of Sites
✿ Study Initiation
✿ Monitoring
✿ Study Closure
✿ ICF, eICF, Inclusion/Exclusion Criteria
✿ CRF Design
✿ Investigation Brochure – IB

MD

✿ Clinical Study Plan, Protocol and Report
✿ Data Management- SAS Programming
✿ Data Entry & Data Analysis
✿ Clinical Event Adjudication
✿ Statistical Analysis
✿ Project Administration/Management
✿ Literature Studies, Clinical Investigational Plan, Clinical Evidence
✿ Clinical Evaluation Plan and Report for Medical Devices