Welcome to Profici, your trusted partner for ISO 13485 certification services. We specialise in helping medical device manufacturers, suppliers, and service providers achieve ISO 13485 certification and maintain compliance with the latest industry standards.
What is ISO 13485 certification? ISO 13485 is an international standard that sets out the requirements for a quality management system (QMS) for medical devices. It helps organisations to ensure that their products meet the regulatory and customer requirements for quality, safety, and efficacy. By achieving ISO 13485 certification, organisations can demonstrate their commitment to quality management and gain a competitive edge in the medical device industry.
Why choose Profici for ISO 13485 certification? At Profici, we have a team of experienced auditors who understand the challenges and complexities of the medical device industry. We offer a range of services, including gap analysis, internal auditing, and certification auditing, to ensure that your QMS meets the requirements of ISO 13485. Our auditors have a deep understanding of the regulations and standards that apply to medical devices and can provide tailored solutions to meet your specific needs.
We are committed to delivering exceptional customer service and support throughout the certification process. We work closely with our clients to understand their unique challenges and provide practical solutions that are aligned with their business goals.
Our ISO 13485 certification process involves the following steps:
- Initial consultation – we will discuss your needs and provide a customised proposal that outlines the certification process and associated costs.
- Gap analysis – we will conduct an assessment of your existing QMS to identify any gaps that need to be addressed before certification.
- Internal audit – we will conduct an internal audit to ensure that your QMS meets the requirements of ISO 13485.
- Certification audit – we will conduct a certification audit to verify that your QMS meets the requirements of ISO 13485.
- Certification – once your QMS has been certified, we will issue a certificate and work with you to ensure that you maintain compliance with ISO 13485.
Contact Profici for ISO 13485 certification If you’re ready to improve your quality management system and achieve ISO 13485 certification, contact Profici today. Our experienced auditors are ready to help you meet the regulatory requirements and quality standards of the medical device industry.