Do you need ISO 13485 or QMS MDR 2017/745 for an effective implementation of the New European Medical Device Regulations? Our Regulatory Affairs and Quality Assurance team can help you understand, plan and implement both ISO 13485, and MDR 2017/745 QMS.As part of implementation, get all our ISO 13485/MDR QMS templates for free!
GAP analysis
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We will help you:
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Asses your exiting processes;
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Compare your exiting QMS to the ISO13485 requirements;
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Create together a plan of implementation;
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Work with you to create your SOP's, Work Instruction, Quality Manual to meet requirement of ISO13485.
Identify process owners
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We will work with you to identify the owners of your own QMS processes (Management review, Internal auditing, Complaints, CAPAs, Complaints, HR, Sales, Customer Services, Manufacturing and Production, Quality Control, Design and Engineering, Distribution, Storage).
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Work with individual teams to build their own processes to meet ISO13485 requirements. Create process mapping and workflows.
Documents, Records and Training
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Our team will help you have all the Quality management system documentation written and approved (SOP's, Work Instructions, Policies, Quality Manual, Quality policy, Quality Objectives)
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We will help you with an internal audit of your records of :
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Management review;
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Non Conformities, Corrective preventive action, if any;
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List of suppliers and their approval;
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Complaints and feedback, if any;
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Training records
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Design control process records..
ISO13485 training
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In order for your team to understand what will be needed during the ISO13485 Implementation plan, our team will provide an ISO 13485 online training course to cover
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a general introduction to ISO13485
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a detailed overview of ISO 13485 requirements
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the process on how to manage the organisation QMS
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how to maintain and comply with the regulatory requirements
Design the documentation
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Identify an eQMS system to start writing documentation
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Work with the owners of each process to cover their own SOPs, Work Instruction based on the ISO 13485 requirements
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Implement your processes such as Design Control, Complaints, CAPA, NCR, Training..
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Start writing the procedures
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assign reviewers and approval for these procedures
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identify the training needs
Certification Audit
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We will help you with the certify body selection, get the cost associated for the certification, get the audit booked for the first Stage 1 audit (typically a one-day audit). Our team will help with the closure of any Nonconformities raised during this Stage 1.
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We will help you book the stage 2 audit which may involve multiple auditors and multiple days. Our team will support you during all these days. Our team will help with the closure of any Nonconformities raised during this Stage 2.
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Once the auditors completes the reports, accept the corrective action plans, the certification body will recommend certification
