ISO 13485 Consultants
Medical Device organizations must appoint experienced ISO 13485 Consultants with knowledge in all risk class devices. The regulatory requirements in the medical device industry are being constantly reviewed and amended accordingly with the increasing emphasis on patient safety.
The organization must manage and extract value from the vast amounts of structured and unstructured information and data, ensuring their organizations stays updated and compliant with the regulatory, regional and local requirements. The organization should implement effective systems to track and monitor safety and benefit-risk information throughout the life-cycle of their products in-line with ISO 13485 requirements.
ISO 13485 consultants or a regulatory consulting team can identify and integrate product-specific regulatory requirements such as MDR or IVDR or FDA 510k during the implementation of ISO 13485.
This will help later when the organization plans for a CE Marking or an FDA 510k clearance.
Role of ISO 13485 Consultants
Consultants help clients with expert guidance for planning, developing and implementing QMS by:
- Identifying the QMS standard requirements
- Identifying all legal and regulatory requirements based on product’s classification
- Planning for establishing the standard requirements stage wise
- Developing and defining the processes and its documentation
- Providing training to the QMS team
- Implementing the QMS
- Conducting internal Quality Audits
- Organizing Management Review Meetings
- Developing a continual improvement approach in the whole QMS
- Evaluating the effectiveness of the QMS implemented in the organization
ISO 13485 Quality Manual
ISO 13485 Quality Manual is considered as the mother document in a QMS system designed for medical device manufacturers.
If you are manufacturing medical devices for use in the EU region with CE Marking you will need to prove compliance with EN ISO 13485:2016. ISO 13485 provides flexibility in how organizations choose the structure of the Quality Manual or how it should be circulated.
ISO 13485 Mandatory Procedures
ISO 13485 implemented organization can have many types of procedures or Standard Operating Procedures or Work Instructions or Protocols based on the processes and activities.
ISO 13485:2016 throughout the standard, in multiple places, has used the words such as “shall, should, must, documented procedures”, which directly warns the organization to keep documentation in the form of procedures. These procedures are commonly called as mandatory procedures.
ISO 13485:2016 & PDCA cycle (Plan – Do – Check – Act)
ISO 13485:2016 follows the PDCA cycle (Plan – Do – Check – Act) which helps to adopt a drive for continuous perfection in the processes of the organization. This approach can improve any processes by dividing it into smaller steps and is effective for the implementation of QMS and helps to improve the whole product realization process.
Also, it provides a range of solutions to problems and helps to select the best one for implementation. This method helps the proper allocation of resources avoiding the wastage for the successful implementation of the solutions.