ISO 13485 Consultant Services

Why Hire an ISO 13485 Consultant?

• Specialized Expertise: Navigate complex medical device regulations with consultants experienced in ISO 13485, FDA QSR (21 CFR 820), and EU MDR.

• Risk-Based Approach: Implement proactive risk management aligned with ISO 14971 to identify hazards, assess risks, and apply controls.

• Efficient Implementation: Leverage proven methodologies and templates to streamline QMS development, reduce time-to-market, and control costs.

• Audit Readiness: Prepare for internal, supplier, and regulatory audits with gap assessments, mock audits, and corrective action plans.

Our ISO 13485 Consultant Services Include:

• Gap Assessment & Roadmap: Detailed evaluation of existing processes and prioritized implementation plan.

• QMS Documentation: Development of quality manuals, procedures, work instructions, and forms.

• Training & Coaching: On-site and virtual training sessions for leadership and operational teams.

• Regulatory Submissions: Support for 510(k), CE marking, and other filings.

• Continuous Improvement: Establish metrics, monitoring processes, and corrective/preventive action systems.

Key Considerations & Insights:

• Integration with Other Standards: Align ISO 13485 with ISO 9001 for broader quality management and ISO 14971 for risk management.

• Supplier Control: Ensure supplier selection, evaluation, and monitoring processes meet QSR and MDR requirements.

• Software & Cybersecurity: Address requirements for software validation and cybersecurity risk management in medical devices.

• Post-Market Surveillance: Implement procedures for complaint handling, CAPA, and trend analysis to drive safety improvements.

Get Started with an ISO 13485 Consultant

Ensure your medical device products meet the highest quality and regulatory standards. Contact Wintersmith Advisory today to speak with an ISO 13485 consultant and elevate your QMS.