ISO 13485: Medical Devices - Quality Management
Ensure the safety and quality of medical devices with ScorePoint Solutions's ISO 13485 certification services.
Introduction
Maintaining quality control in the medical device sector is highly regulated and sensitive, so assuring safety, consistency, and efficiency is essential. One of the best possible ways of accomplishing them is through obtaining ISO 13485 certification.
This internationally recognized certification sets an all-encompassing standard for quality management systems focusing on the design, production, and distribution of medical devices. ScorePoint Solutions helps you achieve this status with expert guidance and auditing services tailored to the medical sector.
Key Features of ISO 13485
Risk Management
Integrates ISO 14971 principles for comprehensive risk assessment of medical devices.
Validation
Rigorous validation of processes to ensure consistent product performance and safety.
Regulatory Alignment
Closely aligned with global regulatory requirements like EU MDR and FDA 21 CFR 820.
Traceability
Ensures full traceability of components and products throughout the lifecycle.
Benefits of ISO 13485 Certification
Global Market Access
Facilitates entry into international markets by meeting standardized quality expectations.
Patient Safety
Directly contributes to safer medical outcomes through stringent quality controls.
Tender Competitiveness
Gives an advantage in healthcare tenders and hospital procurement processes.
Process Efficiency
Reduces waste and rework through clearly defined and validated procedures.
Certification Process
QMS Gap Analysis
Compare your current quality system against ISO 13485 requirements.
Documentation
Create quality manuals, SOPs, and technical files for your medical devices.
Implementation
Implement the QMS and conduct internal audits to ensure compliance.
Audit & Issuance
ScorePoint Solutions performs the certification audit and issues the certificate.