Sponsorships and Speaking Engagements | 29-30 April 2019 | Arlington, Virginia, United States
9th Annual Medical Device Supplier Quality Assurance Conference
Dennis Gucciardo addressed the regulatory clarification on risk assessment within the ISO 13485:2016 framework at the 9th Annual Medical Device Supplier Quality Assurance Conference.
As ISO 13485:2016 places considerable value on risk assessment, original equipment manufacturers (OEMs) seek additional interpretation on regulatory expectations regarding risk-based application approaches for partnering with suppliers and establishing quality requirements. To ensure supplier excellence and examine each component adequately, OEMs must create unique validation traits for varying risk classifications and maintain auditing efforts during the partnership life cycle by periodically reevaluating suppliers in accordance to ISO 13485:2016. Medical device manufacturers must also employ risk based procedures for recording changes in processes and supplier sourcing.
- Differentiating risk assessments based on supplier classification.
- Requirements for purchasing controls and change management.
- Conducting continuous risk-based supplier evaluations.
Learn More: 9th Annual Medical Device Supplier Quality Assurance Conference
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