Regulatory Reliant Internal Auditing for Medical Devices
Regulatory Reliant Internal Auditing for Medical Devices is for existing Internal or Lead Auditors seeking the knowledge & skills to perform internal audits based on integrating ISO 13485, MDSAP and FDA QMSR requirements.
Under Regulatory Reliance models, regulators increasingly depend on the effectiveness of your quality system and the credibility of your internal audit programme to inform audit outcomes, inspection scope, and regulatory confidence.
Many organizations discover this the hard way when internal audits pass, yet MDSAP nonconformities escalate, where FDA inspections uncover gaps that should have been caught internally and when Audit Programmes exist, but do not withstand regulatory scrutiny.
This course is designed for organizations that recognize that internal auditing is now a regulatory control, not a compliance formality. Our live learning methodology focuses on practical ‘learn by doing’ workshops set in a real life context.
Overview of our Regulatory Reliant Internal Auditing for Medical Devices
What's covered on our Regulatory Reliant Internal Auditing Training
Attend live, instructor-led workshops emphasizing practical, real-world application.
- Regulatory Reliance & the Role of Internal Auditing
- Integrating ISO 13485, MDSAP & QMSR
- Risk Based Internal Audit Planning
- Process Based Auditing in a Regulatory Context
- Regulatory Critical Process Auditing
- Conducting Integrated Internal Audits
- Internal Audit Outputs as Regulatory Evidence
- Auditor Competence, Behaviour & Independence
- Sustaining a Regulatory Resilient Audit Programme
Michelle Keane
On completion of this course, successful Learners will have the practical knowledge and be able to apply the techniques needed to:
- Conduct integrated internal audits across ISO 13485, MDSAP, and FDA QMSR
- Identify and document regulatory critical audit findings
- Perform risk-based audit planning and execution
- Generate inspection ready audit reports and follow up actions
- Operate an internal audit programme aligned with regulatory reliance
Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Prior to attending this course, learners are expected to have the following prior knowledge:
- A working knowledge of ISO 13485:2016
- An understanding of the MDSAP audit model and requirements
- Working knowledge with the FDA Quality System Regulation (21 CFR Part 820) and/or QMSR
- Prior recognized training in internal or lead auditing (e.g. ISO 13485 Internal Auditor or Lead Auditor course)
- Experience working within a Medical Device Quality Management System (MD-QMS)
To successfully complete this course, each Learner will need to:
- Fully attend the Instructor Workshops as 100% attendance is required.
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
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Frequently Asked Questions
Yes, very practical. Our live workshops are based on the principles of Accelerated Learning (AL). AL is based on ‘learn by doing’ through practical training methods which include real-world examples, case studies, facilitated exercises and group discussions.
We are passionate about ‘No Death by PowerPoint’ or a ‘sit and listen’ methodology. In fact, there are no slides during the live workshops. Come prepared to be fully engaged and of course, to learn a lot!
Yes, we can deliver training in-person or onsite for in-company groups. However, all our public training is delivered virtually. If you prefer in-person training, get in touch, we are happy to help.
Yes, we offer in-company training provided you have 5 or more learners that can be trained together on the same dates. Please request a quote and a member of our team will be in touch to discuss this further with you.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated, the substitute meets the entry criteria and there is sufficient time available for the replacement to complete the mandatory eLearning and assessments. There is no fee for substitutions.
If the workshop is delivered virtually, there will be a link on your Learner dashboard. This link will become a visible two days in advance of the start date. In addition, a calendar invite is issued.
Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
Comply Guru do not provide learners with copies of international standards, nor do we require that any purchase is made. However, participants do need to have access to a copy of required standard(s) on this training.
Firstly, we suggest seeing if you can obtain a copy of the required standard(s) from a friend, colleague or at your workplace. If you are unable to do so, each country has a nominated ISO standard supplier where you may purchase the international standard(s) you need for your training.
No, there is no end of course examination. However, you must attend 100% of the live workshops and obtain 70% or higher in graded exercises during the live workshops in order to receive certification.
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