SBS - The best value in QMS software

Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed?

C

cabjerk

#1
#1
In Medical device mfg (class 2 13485:2016) is a deviation acceptable? If not or is, where is it stated in the regulations?

Thank you,
 
Join a DISCUS webinar
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
I'm not in medical devices, but I can tell you the first question is - A deviation from what? A print? A processing deviation? An ISO 13485 requirement?

You will have to be more specific.
 
C

cabjerk

#3
#3
From Mfg instructions mainly.
But more of a general question.
We (Quality Group) have had a discussion that in Medical Device NO deviation is acceptable. But I can't find any yes/no in any of the regulations.
 
M

Marcelo

Inactive Registered Visitor
#4
#4
Formally, the acceptance of deviation is more related to the finished product. For example, ISO 13485 allows that a non-conforming final product be liberated under concession if the non-conformity does not affect compliance with regulatory requirements (mainly related to product safety and performance).
 
L

Lokus200

Starting to get Involved
#6
#6
You can release it under concession, however, you cannot do it forever. If for whatever reason that is one-off occurrence you can use a concession, otherwise you need to initiate a change control and update your process.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 8
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
S 21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing Other US Medical Device Regulations 1
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
A Medical Device manufacturing Facility Test audit IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Medical Device Packaging Manufacturing - How should product be stored on the pallet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Help on Medical Device Manufacturing - New Medical Device Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M When is a Manufacturing Date required on Medical Device Labeling? Other Medical Device Regulations World-Wide 12
L Medical Device Manufacturing Equipment Design Other Medical Device Related Standards 2
H FDA/PMA/Medical Device/Before submission/Manufacturing facility change US Food and Drug Administration (FDA) 1
D PPE Requirements in Manufacturing Area of Class IIa Medical Device Other Medical Device and Orthopedic Related Topics 3
M Building Production / Manufacturing Facility for Class 2 Medical Device US Food and Drug Administration (FDA) 1
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Medical Device Manufacturing Process Monitoring Best Practice ISO 13485:2016 - Medical Device Quality Management Systems 2
S Steam Sanitization Requirements for Parts for Medical Device Manufacturing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Medical Device Manufacturing Enterprise License from SFDA China Medical Device Regulations 2
U Manufacturing vs. Production for Medical Device Software in a FDA context 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Medical Device Manufacturing Environmental Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E Risk Management Methods in Medical Device Component Manufacturing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 and Medical Device Manufacturing Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Medical Device Manufacturing in Controlled Environment? How to decide? Other Medical Device Regulations World-Wide 1
P Loctite as Manufacturing Material use in Medical Device Assemblies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
P Control of "manufacturing material" that has adverse effect on the medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Please share a SOP on Medical Device Good Manufacturing Practices (GMP) US Food and Drug Administration (FDA) 8
I Medical Device Exclusivity Period if granted a PMA (Parts Manufacturing Approval) Other US Medical Device Regulations 2
D Sub-Contract Manufacturing of a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer Document Control Systems, Procedures, Forms and Templates 5
H Cooling Equipment Qualification for Medical Device Manufacturing EU Medical Device Regulations 3
Q Class 3 Medical Device Manufacturing Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
somashekar Medical Device Manufacturing License from FDA and State of Location Required? Other US Medical Device Regulations 10
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
U Medical Device Manufacturing License - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q CAPA - Process - Class III Medical Device Manufacturing Nonconformance and Corrective Action 7
E Recording Scrap - Problems in the Medical Device Manufacturing Sector ISO 13485:2016 - Medical Device Quality Management Systems 4
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M PQ and PPQ - Process Qualification for medical device manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Class II medical device manufacturing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q A Non-Quality Culture at a medical device manufacturing company Career and Occupation Discussions 13
C Contract Manufacturing of Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 11
P Startup Medical Device Manufacturing Company Guidance ISO 13485:2016 - Medical Device Quality Management Systems 7
S Components Cleaning for Manufacturing Sterilized Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom