What happens during a Stage 1 MDSAP audit?

racglobal

Involved In Discussions
#1
Hello,

Can somebody shed some light on what happens during a Stage 1 MDSAP audit? Suppose the company is manufacturing a pilot device for the first time, does this mean by Stage 1, we should have manufactured a device and have at our disposal all the documentation associated with the manufacturing of the device? Or is this material for Stage 2 audit?

Can somebody clarify what documentation is reviewed at Stage 1 and what does Stage 2 involve?

Because I am new to this , I'd be interested in knowing what happens at each Stage of the MDSAP audit. I'd appreciate any input.

Thanks
 
Elsmar Forum Sponsor

LUFAN

Involved In Discussions
#2
My previous company's stage 1 was two man days. One off-site day where we sent every document we thought she needed to perform a Doc review, and then about a month later she came on-site and did a 1-Day audit where she selectively looked at processes. At the end of stage 1, she recommended us for a stage 2. We then had to do corrective actions, and have them complete by the Stage 2.

Stage 2 is a full QMS audit where they will look at absolutely everything, some way more in depth than others. On FDA's website there is a audit duration calculator that will tell you based on what you can exclude in your QMS, how long a Stage 2 audit will be. In my experience, count on 4-6 man days depending on the risk of your device.

The tricky part of MDSAP in general is you have to have some documentation and records to support whatever it is you are making. It is very much a "check-the-box" kind of audit. At a minimum you need your procedures, and certainly would make your life easier if you had some records to support it. However, if the standard directly calls something out, you MUST have it. For example, not have having a Preventive Action for review by an auditor is an NC where-as not having some production records because you haven't manufactured may or may not be.

In any case, I would highly highly highly recommend bringing in a contract internal auditor with plenty of MDSAP/ISO experience to cover all your basis. Most importantly hire your Auditing Organization (BSI, Intertek, etc) for a pre-assessment. This allows you to meet your auditors, get an idea of what they are looking for and allow you time to make corrective actions you might have otherwise missed.
 

Jean_B

Trusted Information Resource
#3
The outline given to us by our Auditing Organization stated Stage 1 to be Documentation review and preparedness assessment for Stage 2. It occurred off-site and focused on our documentation (ISO 13485 and region specific) and scope and focus for audits. We did not have a Stage 1 on-site, possibly due to satisfactory hand-in and us complying to some of those regions separately through the same auditing organization before MDSAP.

The documents requested by our auditing organization were :
o Device Marketing Authorization and Facility Registration Procedures, addressing the requirements for the applicable regulatory jurisdictions (facility and device licensing);​
o Facility registration identification numbers for the applicable regulatory jurisdictions;​
o Marketed device listing, classification and licensing or authorizations for the applicable regulatory jurisdictions;​
o Regulatory correspondents or legal representatives and agreements for the applicable regulatory jurisdictions as required (Australia –Sponsor, Brazil – Legal Representative, Canada – Regulatory Correspondent , US – Official Correspondent, Japan – Marketing Authorization Holder (MAH));​
o Procedures for Change Notification to applicable regulatory jurisdictions;​
o Procedures addressing Medical Device Adverse Event and Advisory Notices reporting requirements for the applicable regulatory jurisdictions;​
o Requirements for Labeling demonstrating compliance to labeling requirements of the applicable regulatory jurisdictions (Note: FDA requires UDI labeling for all Class II and III devices).​
The stage 2 we underwent was concurrent with ISO 13485 maintenance audit and CE certificate, which gave them more leeway. The purely MDSAP parts were 'check-the-box' as LUFAN stated. We had 14 man-days and there were indeed in-depth checks at points.

For your pilot device case I would say that actual product(ion) records are only of interest in Stage 2, except for the labeling and already marketed device listing. Perhaps draft labeling would suffice but best to check that beforehand.
 

LUFAN

Involved In Discussions
#5
What is the time frame for getting MDSAP certification for Class IV device?
Canada? Classification of the device doesn't really correlate to the length of an MDSAP audit other the the tangential activities that would go along with higher risk devices such as sterilization, or incorporation of high-risk suppliers, etc. The length of the audit itself can be calculated by looking at MDSAP AU P0008 procedure and form on the FDA site MDSAP Audit Procedures and Forms
 
Thread starter Similar threads Forum Replies Date
M What happens if a Major or Minor Nonconformance is found during Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N What happens after the corrections have been made when audited? General Auditing Discussions 4
M What happens to certifications if the issuing certification body loses accreditation? Supplier Quality Assurance and other Supplier Issues 2
A Brazil: Termination of business relations with BRH – what happens to registrations? Other Medical Device Regulations World-Wide 1
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
C Acquiring an IATF 16949 Certified Company - What happens at the next audit? IATF 16949 - Automotive Quality Systems Standard 4
R In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? ISO 13485:2016 - Medical Device Quality Management Systems 1
D What happens when a company loses ISO 9001 recertification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
B What happens to your ISO 9001 registration if you are acquired by a Company Without ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T What happens in an ISO 9001:2008 Re-Certification Audit? General Auditing Discussions 11
Marc What happens when computers stop shrinking? After Work and Weekend Discussion Topics 3
A What happens if an External Audit NC (Nonconformance) is not closed in 90 days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B What happens if we evaluate supplier as not approved and there are no anothers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
T Already ISO 9001 Certified - What happens when we get ISO 13485 registered? ISO 13485:2016 - Medical Device Quality Management Systems 11
Marc What happens when sleepwalkers go online After Work and Weekend Discussion Topics 3
R Control of Non-conforming Goods (Product) - Tracking what happens to the goods ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
P ISO14001 Certification - What happens if we have several minor audit findings Miscellaneous Environmental Standards and EMS Related Discussions 2
A Only One Automotive Customer - If we lose that customer, what happens to our cert? IATF 16949 - Automotive Quality Systems Standard 6
L Looking for a universal(?) example to illustrate what happens when an error occurs Nonconformance and Corrective Action 4
B FMEA Evolution: What Happens to Recommended Actions? FMEA and Control Plans 7
F Cpk higher than Cp - Explain the relationship and why this happens? Capability, Accuracy and Stability - Processes, Machines, etc. 12
O ISO 14971 on Hazards during service/installation ISO 14971 - Medical Device Risk Management 2
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
E Calibration Records during AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 26
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
G During internal audit - finding poor action plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
G IT being audited during ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G NC criteria during internal audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Confidentiality of information during MD registration worldwide Other Medical Device Regulations World-Wide 0
shimonv Device deficiencies (~complaint) discovered during a clinical trial ISO 13485:2016 - Medical Device Quality Management Systems 3
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
V Handling deviations during analytical method validations Qualification and Validation (including 21 CFR Part 11) 4
G Fractional cycles during sterilisation requalification Other Medical Device Related Standards 5
T Using NICE for guidance during CER CE Marking (Conformité Européene) / CB Scheme 0
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
S Corrections not allowed during audit ISO 13485:2016 - Medical Device Quality Management Systems 7
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
G 60601-1 8.8.3. short circuit of both side during insulation test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Number of people to be interviewed during an internal audit? Internal Auditing 10
G Not accepting a non conformity during an audit General Auditing Discussions 11
S Brexit 100% inspection during in process inspection Manufacturing and Related Processes 11
K Silver Plating corroding possible during SMT Manufacturing and Related Processes 10
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 27
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 10
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 7

Similar threads

Top Bottom