Quality Assurance Audits
Once you have your FDA and/or ISO 13485:2003 quality system in place, you will need routine audits to ensure that the system is compliant and effective. Without regular monitoring, you may see a reduction in product quality, a lack of process improvement, a possible loss of third-party certification, or FDA enforcement action.
Aptiv Solutions offers a variety of audits to meet your specific needs, including:
- Gap Assessment Audits – Typically performed before quality system implementation (QSR, ISO 13485) to identify current level of compliance and areas for possible improvement.
- Pre-certification Audits – An internal audit, performed prior to the official registrar medical device certification audit to identify any outstanding areas of concern.
- Internal Audits – Depending on your needs, we provide two levels of internal audits. During a full on-site audit of your quality system we will review and examine your existing procedures and provide recommendations for improvements. A “desktop” audit focuses only on specific procedures of concern and typically occurs off site, through a review of relevant documents.
- Subcontractor / Supplier Audit – Many medical device companies outsource some or all of the manufacturing of their product. We can perform on-site audits of your vendors and suppliers to give you assurance that your product is being manufactured in accordance with all applicable standards and regulations.
- Due Diligence Audits – A company’s ability to comply with the FDA and other regulatory requirements is a key indicator of its market potential. If you are considering investment or partnership with a medical device firm, we can give you an objective view of its current and possible future regulatory status.