ISO 13485 CERTIFICATION FOR CE MARKING
ISO 13485 Certification is a mandatory requirement for CE Marking and the permission to sell medical devices in the European Union. Before issuing the Certificate Of Conformity, the Notified Body will review the required Technical Documentation and conduct an onsite audit to assess the level of ISO 13485 implementation. The notification body will issue the CE Certificate only if the ISO 13485 implementation is satisfactory.
A Certificate Of Conformity by the Notified Body is required to obtain CE Marking. ISO 13485 Implementation is required for Class I, Class II, and Class II Medical Device CE Marking. However, non-sterile and non-measurable medical devices of Class I can self-declare conformity and they are exempt from Notified Body audit. Class II and Class II Medical Device will need Notified Body audit and certification.
A single audit is only needed if a European notification body is chosen for ISO 13485 Certification, which can save time and money. By choosing ISO 13485 Certification with one certification body (registrar) and choosing a different notification body for CE Marking, 2 audits will be required per year.
ISO 13485 AND GMP FOR MEDICAL DEVICES
In many ways, the ISO 13485 Quality Management System is similar to the FDA Medical Device GMP (21 CFR 820). For a medical device company in the United States to market products in the European Union, it is advisable to develop an integrated quality management system complying with ISO 13485 and FDA GMP requirements.
Integrating multiple quality management systems like ISO 9001, ISO 13485, and Medical Device GMP can be cost-effective and convenient as it helps avoid the burden of keeping multiple quality system documents. Our experienced consultants can help you to implement and certify ISO 13485 or develop an integrated system of multiple ISO or GMP quality management systems.
ISO 13485 AND ISO 9001
ISO 13485 is harmonized with ISO 9001. However, ISO 9001 requires the organization to demonstrate continual improvement. ISO 13485 requires the certified organization to demonstrate that the quality system is effectively implemented and maintained. Customer satisfaction is also a requirement for ISO 9001. This requirement is absent from the ISO 13485 standard.
REQUIREMENTS FOR ISO 13485 CERTIFICATION
- Management’s responsibility for the promotion and awareness of regulatory requirements: For Example, Medical Device manufacturers in the United States are required to comply with Food and Drug Administration (FDA) requirements as per 21 CFR 820 (Medical Device GMP). Quality System Regulation required for doing business in the European Union is Medical Devices Directive 93/42/EEC,
- Requirements for controls in the work environment to ensure product safety
- Requirements to focus on risk management activities and design control activities during product development
- Requirements for inspection and traceability for implantable devices
- Requirements for documentation and validation of processes for sterile medical devices
- Requirements for verification of the effectiveness of corrective and preventive actions
COST OF ISO 13485 CERTIFICATION
The cost of ISO 13485 certification is based on the complexity of your product, the number of locations, the number of employees, and where your organization is in terms of your current quality management system related to ISO 13485 standards.
ISO 13485 CERTIFICATION FEES
ISO 13485 Certification Fees can vary based on the scope of your business, the number of products, location, and the amount of consultation you will require to successfully implement an effective quality management system tailored to your unique situation.
ISO 13485 CERTIFICATION PROCESS
Our ISO 13485 Certification Process involves the following steps:
- GAP analysis: Evaluation of your existing Quality Management System related to requirements ISO 13485 Standards
- Documentation & Records: Development of documents such as quality manual, procedures, forms, templates, etc.
- ISO 13485 awareness training: Training of your staff and management teams.
- SOP: Review of your Standard Operating Procedures
- Implementation: Implementing a well-documented Quality Management System throughout your organization.
- Internal Audit: Identifying non-conformities related to ISO 13485 requirements.
- MRM: Management Review Meetings
- Certification body selection
- CAPA: Corrective and preventive actions /Root cause analysis addressing non-conformities.
- External Audit: ISO 13485 Audit Support:
- Non-Conformities: Closing of any non-conformities found by the certification body (Registrar)
ISO 13485 CONSULTANTS
Liberty Management Group (LMG) has a proven track record of successfully implementing and certifying various quality management systems like GMP, ISO 9001, ISO 13485, CE Marking across the United States for over 14 years. Our experienced and competent ISO 13485 consultants can provide assistance with successfully meeting all the quality management system requirements mandated by the regulatory agencies.
