European Union (EU) Regulatory Requirements for Medical Devices

McGRAIL CONSULTING will assist in establishing the requirements, processes, documentation and relationships to allow product distribution in the European Union member states including:
  • Quality Management Systems - ISO13485
  • Medical Device Directive (MDD)
  • CE Marking
  • Technical File
  • EC Declaration of Conformity
  • Essential Requirements Checklist
  • Authorized Representative
  • Notified Body Engagement
  • Management Representative

FDA Regulatory Requirements for Medical Devices

McGRAIL CONSULTING will assist in establishing the requirements, processes and documentation to become compliant with the FDA's medical device requirements allowing product distribution in the United States (US) including:

  • Quality System (QS) Regulations - 21CFR820

  • Device Classification

  • FDA Engagement

  • Premarket Notification 510(k)

  • Investigational Device Exemptions (IDE)

  • Labeling Requirements

  • Medical device Reporting (MDR)

  • Manufacture Establishment Registration

  • Medical Device Listing

Experience

Services

UNITED STATES

510(k) clearances:

Blood Glucose Meter

Mobile Health Manager Application

Diode Laser System

Alexandrite Laser System

YAG Laser System



EUROPEAN UNION

Products cleared and distributed in the following member countries:

France, Estonia, Germany, Greece, Italy, Poland, Portugal, Spain, UK


Other EU member countries:

Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, Hungary, Ireland, , Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland,  Romania, Slovakia, Slovenia, , Sweden



FOREIGN COUNTRIES

Products cleared for distribution in the following countries:

Argentina (ANMAT registration), Australia (Australian Department of Health), Brazil (Brazilian Health Regulatory Agency – ANVISA), Canada (Canadian Medical Device Regulations), China, Columbia, Egypt, Hong Kong, Israel, Mexico, Japan (PMDA), Poland, Puerto Rico, Russia, Saudi Arabia (UAE Ministry of Health Manufacturer and device registration), Taiwan (Taiwan DOH Requirements), Thailand, Turkey, Uruguay



Product Development

Medical devices designed:

Vascular Lesion Removal Lasers

Hair Removal Lasers

Photocoagulator Eye Laser

Dynamic Cooling Device

Pneumatic Skin Flattening Device

Blood Glucose Meters

Diabetes Manager Applications


Design Control

McGRAIL CONSULTING will assist in establishing the requirements, processes and documentation for medical device compliance to cGMPs, ISO 13485 and Canadian Medical Device Regulations including:
  • Product Development Planning
  • Product Requirements and Specifications
  • Risk Analysis File and Plan - ISO14971
  • Human Factors and Usability File and Plan - ISO62366
  • Clinical Evaluation Plan
  • Validation, Verification and Traceability
  • Design History File (DHF)
  • Device Master Record (DMR)

Foreign country Registrations

McGRAIL CONSULTING will assist in establishing the requirements, processes, documentation and relationships to allow product distribution in foreign counties outside of the US and EU member states including:
  • Canadian Medical Devices Regulations - SOR/98-282
  • Document Notarization
  • Legalization by State Department
  • Legalization by Embassy