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Management review is a requirement of ISO 13485:2016 and is the process of reviewing the quality information generated from the quality management system to ensure that it is working effectively and in line with company policies and objectives.
Internal Audits are a requirement of ISO 13485:2016 and are conducted to ensure that your procedures and documentation are being carried out as intended and are in line with company policy. The audits will highlight any Non-Conformances within the system and put actions in place to correct them.
It is important and a requirement of ISO 13485:2016 that the company has control of its critical suppliers. It is therefore recommended that a supplier audit take place, usually when a critical supplier is first contracted, to ensure they can facilitate the company’s requirements, and then every couple of years for well controlled suppliers or more frequently for suppliers who are not meeting the quality agreement requirements. The audits will highlight any Non-Conformances with the suppliers and put actions in place to correct them.
For companies who subcontract their manufacturing or other critical activities, it is a requirement to have supplier agreements in place to ensure that the services being carried out are in line with what the manufacturer has specified. This is to ensure that both parties are aware of the requirements expected.
Manufacturers of medical devices that use harmonised standards are required to keep and maintain them. This is so that they have the latest versions of the standards and can apply any additional requirements to the design and development life cycle of the device being manufactured. This can be a costly exercise if there are several standards used to demonstrate regulatory conformity.
If a Quality Management System is required in line with ISO 13485:2016 and is also requiring product CE mark certification then the technical file and QMS will need to be audited by a Notified Body (LRQA). It’s recommended that the company is supported with experts in Quality and Regulatory to support the company for any findings or questions the Notified Body may ask on the day of the audit and to support the company through pre-audit preparation and post audit follow up actions if required.
Vigilance and post market surveillance will be required if a product had been placed on the market with adverse incidents being reportable to the MHRA and vigilance put in place for the handling of any potential adverse incidents with the MHRA.
Patient Guard will keep you Informed of any potential items coming up in the future that may impact the company from a regulatory or quality perspective and offer advice to the company on the best approach to manage them.
Risk Management activities should occur on a regular basis to assess any potential risks that have been identified from user, design, manufacturing or post market activities. It is recommended that there be a Quality and Regulatory involvement in these activities to ensure that there are no regulatory or quality associated actions required. It is recommended that these meetings take place quarterly.
Patient Guard will ensure that you have all the correct documentation that is completed correctly and implement it into the business.
We will make sure you’re ready to transition from the Medical Device Directives to the Medical Device Regulations that come fully into force in May 2020.
We will ensure your technical file is completed and structured correctly, we provide a full technical file compilation service from writing a file from scratch to structuring and reviewing an established file.
Biological Evaluation is a very important part of your validation requirement for your medical device, make sure you get the right advice.
Patient Guard will train your staff, so they understand and are competent in operating a QMS and know the regulatory requirements for your business.
Patient Guard will support you with any free advice or information that you may require, this can be done via email or phone and will last the full term of the contract. We aim to answer your queries within 2 business days, during office hours.