Outsourcing is prevalent throughout the medical device industry. Ensuring that your key suppliers are providing you with suitable components and services to support your medical device is imperative. Our team of qualified auditors know how to best approach supplier audits, focusing on the areas that are critical to your device’s quality and ensuring that your supplier matches your organization’s commitment to integrity of quality. We have experience assessing suppliers’ compliance with the niche industry standards that may apply to their component/service but don’t necessarily apply to your company’s operations such as ISO 17025, ISO 11135, ISO 14644 or 21 CFR Part 58..
Whether you need an individual supplier audit or help managing a portfolio of dozens of suppliers from initial outreach/scheduling through nonconformance remediation, our team has the experience to help. In 2019 alone, we successfully conducted more than 80 onsite or virtual supplier audits for our clients.