IVD & Medical Device compliance audits

PharmOut is privileged to have several auditors who have years of experience, either in industry or as regulators who can perform IVD & Medical device compliance audits. Our consultants know the relevant international regulatory codes for Medical Devices (with IVDs being a subcategory) e.g. QSR 820, ISO 13485, ISO 14971 and the GHTF QMS (IMDRF) for medical devices.

IVD (In Vitro Diagnostic) and medical device compliance audits are conducted to assess and ensure that manufacturers of these products comply with relevant regulatory requirements and quality standards. These audits are essential to verify that manufacturers are following proper procedures, maintaining quality control, and meeting the necessary safety and efficacy standards.

Here are some key points about IVD and medical device compliance audits:

1. Purpose: The primary purpose of these audits is to evaluate the manufacturer’s compliance with applicable regulations and standards. These audits help identify any non-compliance issues and ensure that corrective actions are taken to maintain product quality, safety, and efficacy.
2. Regulatory Requirements: IVD and medical devices are subject to different regulatory frameworks depending on the country or region. For example, in the United States, the Food and Drug Administration (FDA) regulates medical devices, including IVDs, under the Code of Federal Regulations (CFR) Title 21, while in the European Union, the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) apply. Compliance audits ensure adherence to these regulatory requirements.
3. Quality Management Systems (QMS): Compliance audits often focus on evaluating the manufacturer’s Quality Management System. A QMS is a set of policies, processes, and procedures implemented by a manufacturer to ensure consistent product quality. Auditors assess whether the QMS meets the requirements outlined in relevant standards such as ISO 13485 (for medical devices) or ISO 15189 (for IVDs).
4. Documentation Review: Auditors review documentation related to product design, development, manufacturing, testing, labeling, and post-market surveillance. This includes records of risk management activities, clinical evaluations, validation studies, complaint handling, and adverse event reporting. The purpose is to verify that the manufacturer has established and maintained adequate documentation systems.
5. Manufacturing Facility Inspection: Compliance audits may involve on-site inspections of the manufacturing facilities. Auditors assess the facility’s infrastructure, cleanliness, equipment calibration, personnel training, and adherence to Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP), depending on the type of product being audited.
6. Corrective Actions: If non-compliance issues are identified during an audit, the manufacturer is expected to take appropriate corrective actions to address these issues. This may involve implementing process improvements, updating documentation, or modifying manufacturing practices. Auditors may follow up to verify the effectiveness of the corrective actions.
7. Regulatory Consequences: Non-compliance with regulatory requirements can lead to regulatory action, such as product recalls, warning letters, fines, or even suspension of market access. Compliance audits help prevent such consequences by identifying and addressing non-compliance issues in a timely manner.

It’s important to note that the specific requirements and procedures for IVD and medical device compliance audits can vary depending on the regulatory framework in each jurisdiction. Manufacturers should familiarize themselves with the relevant regulations and standards applicable to their products and engage in regular internal audits to ensure ongoing compliance.

If you are exporting medical devices to multiple countries that use different regulatory frameworks, we can help you achieve compliance in a practical way, rather than drowning yourself in paperwork.

If you are soon to be audited by a Notified Body or a regulator, or want to ensure you are still compliant after major change, we offer two audit services to assess your compliance to the appropriate codes.

On-site Mock ISO 13485 Audits / Medical Device Compliance Audits

A mock ISO 13485 audits involves:

• A Consultant visiting your site for 2-3 days, just like a regulatory auditor.
• Working with you to create a checklist, appropriate for the type of site and that includes typical sources of non-compliance and the areas you want covered.
• Visually inspecting the site, asking questions and requesting evidence to prove you are following your procedures and meeting regulatory requirements.
• Compiling a report of audit findings. The consultant will also include improvement recommendations if required

Hot tip – If the auditor is following your internal company procedure, they must be trained in accordance with your company QMS. 

A Mock Medical Device GMP Audit is often used to get management attention and resources before a regulatory audit.

Desktop Medical Device Compliance Audits

A cheaper option is a TGA style desktop audit, our consultants use the Desktop Audit format developed by the Australian TGA. This format is also used by some other international regulatory authorities.

A Medical Device Desktop Compliance Audit involves:

• You supplying key QMS documents e.g. your validation master plan and product release records to the auditor.
• The auditor reviewing the documents for regulatory compliance.
• The auditor then calling you for clarification on any problems they find. This might require other documents to be supplied.
• Once all issues have been discussed, the auditor will compile a final report that you can then use to determine your course of action.

More Information

If you would like a quote or would need to ask questions, please contact us.