The Medical Device Single Audit Program is a set of requirements developed by regulatory authorities from different nations to recognize. In simple terms, an audit in one country “must be” recognized in the other countries.
The countries in the agreement are currently: Australia, Brazil, Canada, Japan and the United States.
The program is based on 13485 but it causes the external audit of your organization to occur in a particular sequence. Included in this audit, you will be expected to meet regulatory requirements. If you sell your device in the US and Canada, your MDSAP audit will include verification of the regulatory requirements that you are expected to meet in the US and Canada. The results of the audit will be accepted in both countries, US and Canada.
That is the difference. Previously you would have been audited twice – once by Canada and once by the US – each auditing many of the same things and their own unique requirements per country.
There are no new requirements in the program, just the way in which they are audited. The auditors have to be knowledgeable in up to 5 countries’ regulatory requirements but it is a single audit.
There is no requirement for your organization to internally audit in the fashion of MDSAP and frankly although there are no new requirements, MDSAP does create admin and bureaucracy in audit scheduling, planning, and reporting.
Obviously there is “pressure” to make the external auditors life easier and pre-empt how they audit and demonstrate you have looked at yourself in the same way they are going to.
There is no requirement to do so, but it just makes sense to align your internal audits with how the external auditor will audit. We have seen strong suggestions from ISO auditors to do this too.
At Cavendish Scott, we have developed a planning tool and auditing checklist that allows us to reorganize your audit. We conduct the audit to MDSAP and ensure that all the questions are asked and the checklists are checked. In addition to our full audit report and comprehensive audit evidence, we generate a complete MDSAP report verifying that all the requirements were audited correctly and completely. Our thorough report also includes findings, nonconformance’s and observations. If there is anything for you to do you get it clearly defined and documented.
We can do your MDSAP internal audit for you.
Our approach to any type of internal auditing is unique. We get to focus directly and fully on your organization. We are organized and document your audit thoroughly. Providing you every detail along the way.
We communicate each requirement with you. Especially outstanding issues to be known and what your next steps should be. We want to make sure all your questions are answered. Leaving you confident and not confused.
We are internal auditors that can provide solutions, improvements, and recommendations. We are professional and have years of experience. And we’d like to put our expertise to use and provide improvements for any unique situation.
We know the requirements to check for as we audit your processes. We know and learn best practices everyday as we perform audits. We’ve learned the ins and outs of different situations and how to achieve the ticket to pass.
We coach and assist your employees by providing answers to help them understand how to explain solutions. We want them to feel comfortable and ready in all audits. Foe example, the external audit.
We guarantee what we do. We guarantee that we will find everything before the external auditor does.
Our audits are professional, helpful and we guarantee success. And we can do it MDSAP!
If you need thorough and effective audits, tell us about your organization (size and what you do) and the audits you need and we’ll give you costs and options.