QA & RA Consultancy for Medical Devices
With 20+ years of experience, our experts will be happy to provide you with tailored QA&RA Consultancy for medical devices. Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed information about the revised regulatory requirements, you will find a suitable solution within MEDLOFT consultancy services.
The basics of a consultancy project consist of the following milestones;
Gap Analysis
As a first step, we perform a detailed gap analysis against applicable legal requirements and product standards. During this analysis, our experts will define details of your current product realization processes, review your current control methods related to process and product safety. They will define the project needs and improvement opportunities in detail.
Risk Analysis
Our experts will perform a detail risk analysis with your staff. Parallel to the gap analysis this will enable to define additional improvement opportunities in your system. They will perform the risk analysis in line with the applicable standards and regulations such as ISO 13485, ISO 14971,ISO TR/24971, IEC 62366,FDA QSR, MDR, IVDR, and technical product safety standards.
Project Plan
Our experts will prepare a detailed report according to findings of the gap and risk analysis. They will present this report to the top management together with a project plan. This project plan will include project milestones, detailed action plans with target dates and responsible persons.
Documentation
Our experts and your project team will prepare the documents needed for quality and regulatory compliance according to your project plan. Our experts will provide online and onsite support to your project team continuously. They will review the initial drafts under PDCA (plan, do, check, act) principle until the final version of the document is reached.
Implementation
The prepared documents such as procedures, work instructions will be implemented within your quality management system. This will enable establishing the required records for quality and regulatory compliance.
Audit
Our auditors with Notified Body experience will audit the quality management system and product technical documentation. The audit reports and related nonconformities will enable to start further corrective actions, which will be planned and implemented under coordination of our experts.
Effectiveness Check
Our experts will check the results of each corrective action will be checked for effectiveness to ensure that there are no further gaps within the quality management system and technical documentation. If they cannot verify the effectiveness of the implemented actions, further corrective actions will be planned under PDCA principle.
During the consultancy services, all activities of your company will be analyzed and appropriate quality management system requirements together with organizational benefits will be implemented according to your company profile. At the end of each month, the status of the project will be reported to the top management.
All information exchanged between your company and MEDLOFT is kept confidential. It will be never shared with third parties. This is a commitment given in MEDLOFT policy and confidentiality agreement will be signed at the beginning of the project.
