Medical Device Industry Quality Solutions
Avoid Costly Defects and Ensure Compliance
Pro QC has experience with a range of products designed to diagnose and treat patients in healthcare systems worldwide. From tongue depressors to highly technical imaging systems, key products that comprise the industry include surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, irradiation apparatus, in-vitro diagnostic substances, dental and ophthalmic goods.
Supplier or Factory Audits
Factory Audits often include:
The benefits of performing ISO 13485 based audits go beyond required certification. With an effective and efficient quality system, organizations are able to identify errors early in the process, avoid costly regulatory fines and provide employees with appropriate training.
FDA 21 CFR Part 820
In Section 820.22 of the Code, a quality audit is prescribed. “Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the QS is in compliance with the established requirements and to determine the effectiveness of the QS. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.”.
Process audits help identify the root cause(s) of issues on-site and recommends corrective actions for continuous improvement.
Social Responsibility (CSR)
SR audits evaluate suppliers using the SA8000, ISO 26000 or other applicable CSR standards. These evaluations focus on health and safety, discrimination, disciplinary practices, working hours, compensation, management practices, forced labor, freedom of association and child labor laws
Quality Control Inspections often include:
Pre-production (first article) inspections
Pre-production inspections help you in the process of approving parts/components/products.
In-process inspections to monitor that the established product methodology and techniques are being followed and to verify that manufacturing process can flow smoothly towards meeting the product’s engineering specification requirements and reliability.
Pre-shipment inspections to check the product’s quality throughout the relationship with the supplier.
- Environmental & Weathering