Medical Devices Consulting - ISO 13485 Audit

By: Real Regulatory  05/12/2011
Keywords: Risk Management, Medical Device, medical devices

General Services:

  • Regulatory and Technical review and consulting
  • Preparation and submission of registration for product applications
  • Clinical Trial Applications
  • Medical device vigilance and reporting systems
  • Regulatory and manufacturing compliance
  • Strategic and regulatory planning
  • Auditing of Quality & Regulatory system to ensure compliance with required quality systems & regulations
  • Regulatory/Quality GAP Analysis
  • Interpretation of guidance documents and legislation
  • Assistance with device labelling requirements
  • Liaison with Regulatory Authorities
  • Provide medical device classification
  • Risk Management (ISO 14971)

European Services

  • Preparation and submission of EU Regulatory documentation including:
    • Technical Files
    • Design Dossiers
  • Liaisons with EU Competent Authorities and Notified Bodies
  • Implementation of Device Directive requirements
  • Determination of product classification
  • Pre-/post-inspection audits to ISO 9001:2008 , ISO 13485:2003
  • Standards Update
  • Company specific training
  • Provision of European Authorised Representative Services

US Services

  • Pre-market Notification 510 (k)
  • New Products
  • Product/ Process changes
  • New Intended use
  • Pre-market Applications (PMA)
  • Establishment Registration
  • US FDA Liaison including pre-submission meeting if required
  • Provide medical device classification and pre-market strategy
  • Monthly/ Quarterly Medical Device Reporting
  • Post-Market Requirements
  • Perform regulatory GAP analysis
  • Compliance program development
  • GMP Quality System expertise

See also:

Keywords: Clinical Trial, Competent Authorities, Medical Device, medical devices, Risk Management

Other products and services from Real Regulatory


Clinical Trial Regulatory Consulting

At Real Regulatory, our experienced team will drive your clinical trial regulatory requirements and will respond to your specific needs, whether that is a phase I, single site study or a phase III global, multi-centred mega-trial. Strategic advice and preparation of key submission documents, such as the Investigator Brochure, Investigational Medicinal Product Dossier and protocols.


Regulatory Quality Assurance - Regulatory Compliance

Develop and implement an ISO 13485:2003 or ISO 9001:2008 quality management system (or parts thereof) including CMDCAS. Conducting pre-inspection audits to assess readiness for quality management system certification/registration. Conducting audits on behalf of client companies (supplier audits / internal audits.


Cosmetic Regulatory Legislation - Food Supplement Classification

Review of clinical studies to document safety of ingredients, and to substantiate label claims. Classification of cosmetics products and cosmetics justifications for borderline products. Interpretation of guidance and legislation, as they relate to products or practices. Reviewing food supplement labels/advertising for compliance with regulations. Liaison with the competent authorities on behalf of our clients.


Pharmaceutical Regulatory Affairs

Preparation, submission and follow up of Scientific Advice and Orphan Drug Designations. Preparation and submission of Marketing Authorisation Applications. Submission and follow up of Paediatric Investigations Plans. Variations Type I, Type II and urgent safety restrictions. Submission and follow up of clinical trial applications. Performance of PIL user testing.


Pharma Regulatory Affairs

We have capabilities across the spectrum, that allow us to deliver most requirements – they include all the procedures that relate to the life cycle of NCEs, devices and diagnostics, known compounds, and Quality Assurance matters, amongst others. There are a wide number of regulatory affairs activities that might be needed across the pharma and related industry sectors where Real Regulatory has expertise.