Available Services

ISO 13485 Implementation: Develop and implement QMS in compliance with ISO 13485 for medical device manufacturers.

QMS Auditing: Perform internal audits and supplier audits to assess compliance and identify areas for improvement.

Gap Assessments: Evaluate existing QMS against regulatory requirements and industry standards.

Document Control: Establish robust document and record management systems for regulatory compliance.

Six Sigma Training: Offer Six Sigma Yellow or Green Belt training for client teams.

Quality and Compliance Training: Conduct workshops on ISO 13485, process validation, and regulatory requirements.

Root Cause Analysis (RCA): Train teams in problem-solving techniques, such as RCA and CAPA.

Process Validation Protocols: Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

Statistical Process Control (SPC): Implement SPC to monitor and improve manufacturing processes.

Design of Experiments (DOE): Optimize processes using DOE to analyze multiple factors affecting quality.

Equipment Qualification: Support equipment calibration and validation (e.g., 3D printers, testing equipment).

Lean Manufacturing Initiatives: Identify and eliminate waste in manufacturing processes to improve efficiency and cost-effectiveness.

Complaint Handling Systems: Set up or improve complaint handling processes to comply with FDA and ISO requirements.

CAPA Management: Develop Corrective and Preventive Action systems to address recurring issues.

Post-Market Surveillance Plans: Create plans to monitor device performance and ensure ongoing safety and efficacy.

ISO 14971 Compliance: Develop and maintain risk management files in accordance with ISO 14971.

Failure Mode and Effects Analysis (FMEA): Conduct FMEA for product design and processes to identify and mitigate risks.

Hazard Analysis: Support regulatory submissions with detailed hazard analysis reports.

Supplier Audits: Evaluate and approve suppliers to ensure compliance with regulatory requirements and QMS.

Supplier Development: Collaborate with suppliers to improve their quality systems and processes.