What to expect if FDA wants to inspect a Class 1 Medical Device Manufacturer

A

Aphel

Involved In Discussions
#1
#1
Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Re: Class 1 Device Manufacturer - FDA Inspection

Aphel said:
Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel
Click to expand...
Have a look here
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
K IT Specialist /FDA - Interview Questions to Expect Career and Occupation Discussions 5
T What would the FDA expect to see when they ask for our QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
GreatNate What to expect during an ISO 9001 audit Manufacturing and Related Processes 42
M Informational UK – Businesses supplying medicines and medical devices – what to expect on day one of a ‘no deal’ scenario Medical Device and FDA Regulations and Standards News 1
supadrai What to expect when moving to higher-risk medical devices? Other Medical Device and Orthopedic Related Topics 1
P REACH - BOMcheck.net - What I can expect from this service? REACH and RoHS Conversations 0
J What to expect during a Change of Location Audit under AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
S What to expect in an ISO 9001:2015 Lead Auditor Certification Course Training - Internal, External, Online and Distance Learning 9
A What to expect in a Design Dossier Review for CE Marking by a Notified Body CE Marking (Conformité Européene) / CB Scheme 3
R What can I expect in a Government Source Inspection? Quality Manager and Management Related Issues 13
R What to expect from an "MDD" Audit EU Medical Device Regulations 2
S What Type of Audit Questions to expect for ISO 9001 - 6.2 Human Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C What to expect in a GE Aerospace Audit of a 100 Person Machine Shop Customer and Company Specific Requirements 5
Q DNV IEC 64100 Manufacturing Evaluation - What to expect? Other ISO and International Standards and European Regulations 4
Q Spin Off and Divestment from Corporate - What to expect Quality Manager and Management Related Issues 10
bobdoering Capability Brain Teaser - Which distribution do you expect to see Capability, Accuracy and Stability - Processes, Machines, etc. 5
T What to expect during a Construction Company OHSAS 18001 Site Audit? Occupational Health & Safety Management Standards 4
A What do you expect from a packaging manufacturer? Manufacturing and Related Processes 3
Q Upcoming FAA Audit - What to expect (subtier for a Repair station)? Federal Aviation Administration (FAA) Standards and Requirements 5
H Meeting following an interview, what should I expect? Career and Occupation Discussions 15
J What to expect when a Critical Supplier moves? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
G Management of Change Process (OHSAS) - What would an Auditor expect to see? Occupational Health & Safety Management Standards 6
J What to expect during Stage 1 and Stage 2 audits - Certification Audit ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M AS9100 Getting Started - What time frame /cost / major obstacles can we expect AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Stijloor What do "Six Sigma" Companies expect from Six Sigma "Yellow Belts?" Six Sigma 14
D TS16949 Consultancy - What should I expect from a TS16949 Consultant? IATF 16949 - Automotive Quality Systems Standard 14
Hershal For accredited labs that expect more - Certification of ISO/IEC 17025 assessors ISO 17025 related Discussions 4
B How to expect the value of Sampling Uncertainty Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K What do you expect from a new position? Let?s compare benefits Career and Occupation Discussions 18
Q Promoted to "Maintenance Manager - What should I expect in an ISO / QS9000 audit? QS-9000 - American Automotive Manufacturers Standard 6
C Interview with Quality Director and Manufacturing Director - Questions to Expect? Career and Occupation Discussions 14
F AS 9110 Accreditation - Can anyone tell me what to expect? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M What distribution should I expect a tensile strength test to fit? Statistical Analysis Tools, Techniques and SPC 10
D ISO 6508-2 and Hardness Gage Testers - Apostrophes where I expect a decimal point Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Manix What do Automotive OEMs expect in terms of Quality accreditiations IATF 16949 - Automotive Quality Systems Standard 8
C The future of quality training - What training do you expect in your organization? Training - Internal, External, Online and Distance Learning 30
B BSI PreAssessment Visit ISO 94-2000 - What to expect? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S What is a Desk Audit? What should I expect? A Document Review? IATF 16949 - Automotive Quality Systems Standard 4
D Toyota Japan Coming for an Audit - What should I expect? Customer and Company Specific Requirements 3
E ISO 9001:2000 Upgrade - What costs can a company expect to incur in the changes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S QS-9000 Coordinator - What is the average salary I should expect? Career and Occupation Discussions 2
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2

Similar threads

Top Bottom