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openregulatory
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templates
Templates for ISO 13485, IEC 62304, ISO 14971 and IEC 62366 compliance.
https://openregulatory.com/templates
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License disagreement
#48
Mathnerd314
opened
2 months ago
4
Template Updates Q2-2024.md
#47
sven-pa
opened
3 months ago
0
ISO 27001 Templates: First Batch
#46
olieidel
closed
3 months ago
0
Apply correct conformity assessment in DoC for class I devices
#45
cmaas
closed
3 months ago
1
Inline Copyright Notice
#44
olieidel
closed
4 months ago
0
Update sop-purchasing.md with fixed heading number reference
#43
oddgoo
closed
4 months ago
1
Minor spelling & numbering error
#42
sven-ka
closed
4 months ago
0
Update software-development-maintenance-plan.md
#41
oddgoo
closed
4 months ago
1
Minor corrections
#40
sven-ka
closed
6 months ago
0
Sven New Templates
#39
sven-pa
closed
2 days ago
0
Q1-2024 Sven Template Updates.md
#38
sven-pa
closed
3 months ago
0
Corrected minor issues
#37
opensoeren
closed
7 months ago
0
Seb Q4 Template Updates
#36
seb-open
closed
6 months ago
0
Create SOP for ML Development
#35
sven-pa
closed
9 months ago
0
Q4 Template Updates
#34
sven-pa
closed
7 months ago
0
Updates of Templates
#33
sven-pa
closed
10 months ago
0
Update software-development-maintenance-plan.md
#32
opensoeren
closed
1 year ago
0
Added Appointment Letter PRRC Template
#31
opensoeren
closed
1 year ago
0
Improved Usability of SCL
#30
opensoeren
closed
1 year ago
0
Update of templates, most of them due to CA audit
#29
sven-pa
closed
1 year ago
0
New templates
#28
sven-pa
closed
1 year ago
0
Update of Templates
#27
sven-pa
closed
1 year ago
1
Updates based on MDCG 2023-03
#26
sven-pa
closed
1 year ago
0
Separating PMSR and PSUR
#25
opensoeren
closed
1 year ago
0
Deleting MDD references
#24
opensoeren
closed
1 year ago
0
Added reference to MDR checklist
#23
sven-pa
closed
1 year ago
0
Addition to instructions for Quality Policy
#22
opensoeren
closed
1 year ago
0
Add PO and KPI to SOPs
#21
opensoeren
closed
1 year ago
0
Created List of Regulatory Requirements template
#20
opensoeren
closed
1 year ago
0
PSUR Template Update acc. to MDCG 2022-21
#19
opensoeren
closed
1 year ago
0
SOP risk management
#18
SimonBiggs
closed
1 year ago
1
Update of templates
#17
sven-pa
closed
1 year ago
0
Document and Record Control. Wording Update.
#16
sven-pa
closed
1 year ago
0
Create SOP Sales
#15
sven-pa
closed
1 year ago
0
updated clinical evaluations templates
#14
nicospinu
closed
1 year ago
0
OpenReg Template Updates
#13
sven-pa
closed
1 year ago
0
Cre(a)ted a Document Roadmap
#12
opensoeren
closed
2 years ago
0
Open for integration with Jupyter Book and GitHub pages?
#11
SimonBiggs
closed
1 year ago
3
Update of OpenReg templates
#10
sven-pa
closed
1 year ago
2
Updated PMCFP and CER templates, added SA templates
#9
sven-pa
closed
2 years ago
0
Created additional QMS / TD templates
#8
sven-pa
closed
2 years ago
2
HRA: update reference
#7
sven-pa
closed
2 years ago
0
Lageso changes
#6
sven-pa
closed
2 years ago
1
Lageso: max. surveillance cycles
#5
sven-pa
closed
2 years ago
0
Lageso: updated PRRC responsibilities
#4
sven-pa
closed
2 years ago
0
Lageso: refer to processes for change implementation
#3
sven-pa
closed
2 years ago
0
Fix reference to Risk Control Measures
#2
dloeckx
closed
2 years ago
2
LaGeSo Audit Results
#1
sven-pa
closed
2 years ago
0