Manufacturing requirements for respiratory ventilators - clean room required?

Thread Attachment browser
V

VirginiaA

Registered
#1
#1
Hello Elsmar Cove community,

Does anybody here know if you are required to manufacture respiratory ventilators in a clean room? I could not find any specific requirements aside form ISO 13485 and CFR 820. I was asked by somebody who is interested in manufacturing emergency ventilators.

Thank you!
 
How to manage your QMS while working remotely.
Elsmar Forum Sponsor
blackholequasar

blackholequasar

Involved In Discussions
#2
#2
It would be best to check with the FDA directly (if they are manufacturing in the US). There doesn't seem to be a lot of information out there just yet on this. I certainly wish whoever it is well in their endeavor, I know we are in dire need of them!
 
Johnnymo62

Johnnymo62

Haste Makes Waste
#6
#6
I don' think clean rooms are necessary, but following the Good Manufacturing Practices should be sufficient. They are not used internally.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 22
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
Q 21 CFR Part 111 - Requirements for Dietary Supplement Manufacturing Water Quality Document Control Systems, Procedures, Forms and Templates 1
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
M Orthopedic Devices and Implants Manufacturing Cleanliness Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
C Financial Records Retention Requirements for a Manufacturing Company Records and Data - Quality, Legal and Other Evidence 3
G Temperature Requirements for a Manufacturing Inspection Lab General Measurement Device and Calibration Topics 5
D PPE Requirements in Manufacturing Area of Class IIa Medical Device Other Medical Device and Orthopedic Related Topics 3
A Product Realization Requirements in a Non-Manufacturing Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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 Environmental Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M 7.2.2 Review of Requirements Related to the Product (Design-Manufacturing Service) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
V Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
C International Supplier Audit (ISO9001:2008 + Manufacturing Requirements) Supplier Quality Assurance and other Supplier Issues 4
A Temporary Change of Manufacturing Site - Notified Body Notification Requirements EU Medical Device Regulations 3
S TS 16949 Requirements for Remote Manufacturing Sites IATF 16949 - Automotive Quality Systems Standard 7
R 7.2.1 Customer Requirements Checklist for a Small Contract Manufacturing Machine Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M Manufacturing Equipment Pressure Gages Calibration Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
L FDA Manufacturing Site Requirements Other US Medical Device Regulations 4
W Requirements of Contract Manufacturing in respect to GMP? ISO 13485:2016 - Medical Device Quality Management Systems 13
A Re-Validation criteria and Requirements for Manufacturing equipment on site ISO 13485:2016 - Medical Device Quality Management Systems 8
K ISO 13485 Audit requirements - Manufacturing requirements in draft? ISO 13485:2016 - Medical Device Quality Management Systems 12
G Medical Device 510k Requirements - Plan to expand the manufacturing site in Malaysia US Food and Drug Administration (FDA) 11
P Legal Requirements for Electrical Panel Manufacturing Industry Various Other Specifications, Standards, and related Requirements 3
A What is the expectation of Lean manufacturing plans in Visteon specific requirements Customer and Company Specific Requirements 0
Q Quality vs. manufacturing personnel requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
Q Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
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
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
Similar threads
Top Bottom