Services Medical Devices Quality Management and Training
Quality Management and Training
An effective QMS for the lifecycle stage of your product is vital to ensuring safety and quality of your medical device.
Services Medical Devices Quality Management and Training
An effective QMS for the lifecycle stage of your product is vital to ensuring safety and quality of your medical device.
At DLRC, our consultants have the expertise to ensure that you meet stringent global quality requirements such as the US FDA Quality System Regulation (QSR), EU Medical Device Regulation, ISO 13485 and MDSAP (Australia, Brazil, Canada, Japan and US).
Each QMS must be bespoke to the organisation and also compliant with the applicable requirements. DLRC are able to tailor each QMS to suit the manufacturer in order to remain compliant while being efficient and effective for the purposes of Quality Management.
In order to remain compliant with requirements, internal audits must be conducted of the QMS. Internal Audits must be conducted by trained auditors. DLRC have auditors with extensive experience in conducting internal audits, supplier audits and Notified Body audits and can provide this service to the relevant regulations.
Quality Gap Assessments are an efficient way to review a QMS to determine its suitability for use or compliance with a relevant standard or regulation. DLRC is able to offer this service for any QMS type to provide a report with all gaps and suggested remediation.
Gaps in the QMS system can be remediated in a number of ways to meet compliance. At DLRC we have vast experience in remediating systems with many different types of practical measures and examples to use for the remedy of our clients systems.
Internal audit training is a requirement for all Internal Auditors. At DLRC we have experience in auditing and internal audit training and are able to provide internal audit training to comply with the requirements. This training can be performed at the clients premises or at DLRC office by our experienced auditors.
ISO 13485 training has been found to be a very useful resource for many medical device companies. At DLRC we have experience in ISO 13485 implementation and management as well as training of this standard. This training can be performed at the clients premises or at DLRC office by our experienced QMS experts.
Risk Management and ISO 14971 training has been found to be a very useful resource for many medical device companies. At DLRC we have experience in Risk Management System creation and management as well as training of this standard. This training can be performed at the clients premises or at DLRC office by our experienced Risk Management experts.
MDSAP training has been found to be a very useful resource for many medical device companies. At DLRC we have experience in MDSAP System auditing, system creation and management as well as training of this programme. This training can be performed at the clients premises or at DLRC office by our experienced MDSAP experts.
Regulatory requirements have resulted in a need within the industry for clinical/ performance evaluation writing skills to become the norm for all medical device companies. DLRC has great experience in clinical/ performance evaluation and providing the needed training for authors within companies. This training can be performed at the clients premises or at DLRC office by our experienced experts.
Understanding MDR and IVDR is a must from the outset of any medical device company. DLRC has great experience in MDR/IVDR and provides the needed training for companies. This training can be performed at the clients premises or at DLRC office by our experienced experts.
