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CE certification consultancies for medical devices
A. CE CONSULTANCY FOR MEDICAL DEVICES
CE MARKING FOR MEDICAL DEVICE MANUFACTURER:
Complete guidance through the entire CE marking process under EU MDR 2017/745, from initial classification to final certification, ensuring successful market entry into European countries.
TECHNICAL FILES FOR MEDICAL DEVICE:
Comprehensive development and compilation of technical documentation that demonstrates compliance with MDR requirements, including device description, design information, manufacturing processes, and verification/validation data.
RISK MANAGEMENT FOR MEDICAL DEVICE:
End-to-end implementation of risk management system as per ISO 14971, covering risk analysis, evaluation, control measures, and ongoing risk monitoring throughout the device lifecycle.
GENERAL SAFETY AND PERFORMANCE REQUIREMENT (GSPR):
Detailed gap analysis and compliance strategy for all applicable GSPRs from Annex I of MDR, ensuring your device meets all essential safety and performance criteria.
INSTRUCTION FOR USE (IFU):
Professional development of multilingual IFU documents that are clear, comprehensive, and compliant with regulatory requirements for all target markets.
LIST OF APPLICABLE STANDARDS:
Expert identification of relevant harmonized standards (EN ISO, EN IEC) and international standards that provide presumption of conformity to MDR requirements.
SSCP:
Preparation of Summary of Safety and Clinical Performance documents for Class III and implantable devices, ensuring transparent information disclosure to healthcare professionals and patients.
MEDICAL DEVICE TESTING:
Strategic guidance on required testing protocols including biocompatibility, electrical safety, electromagnetic compatibility, software validation, and performance testing.
USABILITY:
Human factors engineering support covering user interface design validation, use error analysis, and usability testing to ensure device safety and effectiveness in real-world conditions.
DESIGN HISTORY FILE(DHF):
Structured development and maintenance of design history files that provide complete traceability from design inputs to verified outputs and validation.
STABILITY STUDY:
Comprehensive stability study design and documentation to establish and verify shelf life, packaging integrity, and device performance over time.
- VALIDATION:
Complete validation services for critical processes including sterilization, cleaning, packaging, software, and manufacturing processes to ensure consistent quality outputs.
B. CE CONSULTANCY FOR IN VITRO DIAGNOSTIC DEVICES (IVDs)
TECHNICAL FILES:
End-to-end development of IVDR-compliant technical documentation including device description, intended purpose, and demonstration of conformity.
RISK MANAGEMENT FOR IVD:
Implementation of risk management systems specifically tailored for IVD devices, addressing unique risks associated with diagnostic testing and results interpretation.
GENERAL SAFETY AND PERFORMANCE REQUIREMENT (GSPR):
Comprehensive gap analysis and compliance strategy for IVD-specific GSPRs under IVDR, ensuring device safety and performance.
PERFORMANCE EVALUATION REPORT:
Development of robust performance evaluation reports demonstrating scientific validity, analytical performance, and clinical performance of IVD devices.
STABILITY STUDY:
Design and documentation of stability studies for reagents, calibrators, and control materials to establish shelf life and storage conditions.
SSP:
Preparation of Summary of Safety and Performance documents for IVD devices requiring public disclosure under IVDR regulations.
IVDs TESTING:
Guidance on performance study requirements, analytical performance testing, and clinical performance studies specific to IVD devices.
DESIGN HISTORY FILE:
Comprehensive documentation of design and development processes for IVD devices, ensuring complete traceability and regulatory compliance.
- VALIDATION:
Validation services for IVD-specific processes including assay validation, software validation, and manufacturing process validation.
INSTRUCTION FOR USE (IFU):
Development of IVD-specific instructions for use that are clear, comprehensive, and compliant with target market requirements.
LIST OF APPLICABLE STANDARDS:
Identification of IVD-specific harmonized standards and common specifications relevant to your device type and technology.
C. CLINICAL EVALUATION FOR MEDICAL DEVICES
CLINICAL EVALUATION PLAN:
Development of comprehensive clinical evaluation plans that define the scope, methodology, and acceptance criteria for clinical evaluation.
CLINICAL EVALUATION REPORT:
Preparation of detailed clinical evaluation reports that systematically evaluate clinical data to demonstrate device safety, performance, and positive benefit-risk profile.
D. Post Market Surveillance (PMS)
POST MARKET SURVEILLANCE REPORT(PMSR):
Preparation of periodic post-market surveillance reports for Class I devices, summarizing collected data and conclusions.
POST MARKET CLINICAL FOLLOW-UP (PMCF):
Planning and execution of PMCF studies to proactively collect clinical data on device performance in real-world settings.
PERIODIC SAFETY UPDATE REPORT (PSUR):
Compilation of PSURs for Class IIa, IIb, and III devices, providing regular safety updates and benefit-risk reassessments.
POST MARKET PERFORMANCE FOLLOW-UP (PMPF):
Specific to IVDs, planning and reporting on post-market performance follow-up activities to confirm continued safety and performance.
E. NOTIFIED BODY SELECTION SERVICE:
Strategic guidance in selecting the most appropriate Notified Body for your device type, including preparation for and management of the qualification audit process.
F. MDD VS MDR- GAP ANALYSIS:
Comprehensive analysis of existing technical documentation and quality systems to identify gaps between Medical Device Directive and Medical Device Regulation requirements, with actionable remediation plans.
G. EUROPEAN AUTHORIZED REPRESENTATIVE(EAR):
Professional representation service for non-EU manufacturers, ensuring compliance with MDR/IVDR requirements and serving as your legal entity in the European Union.