There are many reasons why ISO 13485 certification is important to a medical device company, including:
■ Increases customer confidence: Certification establishes a company’s commitment to quality, which often leads to increased customer confidence;
■ Enhances marketing and promotional opportunities: Once a company has been deemed compliant by a certified ISO 13485 registrar, it will receive a certificate. The company’s marketing team will be able to display this certificate on all corporate marketing materials to enhance its credibility in the eyes of customers, employees and other stakeholders;
■ Promotes better communication/fewer deviations: ISO 13485 promotes harmonization of regulatory requirements on an international scale. Harmonization allows device manufacturers and other quality experts to communicate using a familiar/standardized vocabulary. This reduces communication gaps and ambiguity that often result in deviations, non conformances and other quality events that can cause patient harm, regulatory sanctions and significant revenue loss;
■ Improves performance and supplier relationships: Using a uniform, widely-accepted system of process control leads to improved products and processes. This in turn often leads to increased customer satisfaction and better relationships with suppliers and partners;
■ Enhances brand equity: Improved products and processes help device manufacturers sustain their delivery of high quality products, and minimize or avoid embarrassing product recalls and costly regulatory sanctions. Ultimately, this leads to increased brand equity, which is an important competitive advantage.
■ Increases Speed to Market: ISO 13485 certification allows an organization to meet the quality system requirements of the European Medical Device Directive (MDR), In Vitro Medical Device Directive (98/79/EEC) and Active Implantable Medication Device Directive (90/385/EEC) with less difficulty, which expedites market entry.
