SBS - The best value in QMS software

Software for maintaining of Technical files and medical device documentation(RA need)

J

jan.stepanek

#1
Dear All,

can I please you for some recomandation of software for maintaining Technical files and medical device documentation at all? In the case I would like to focus on companies which have experiences in the area of medical devices and have a software solution fit for this type of products.

Thank you
Jan
 
Elsmar Forum Sponsor
S

SteveK

#2
Re: Software for maintaining of Technical files and medical device documentation(RA n

I personally use Adobe Acrobat 9 for my Technical Files. First creating documents such as Essential Requirements, Risk Management, and Usability etc in MS Word and then I convert them to .pdfs. You can create hyperlinks to navigate around the document, marking them up as highlighted words etc. It is easy to insert extra pages where you want, and utilizing other editing functions. My NB seems OK with this format.

Steve
 
S

SteveK

#3
Re: Software for maintaining of Technical files and medical device documentation(RA n

By the way Acrobat is now up to Pro DC. Just been waiting (forever) for our IT guy to do an upgrade! Loads more bells and whistles ? plus the Cloud.

Steve
 
Thread starter Similar threads Forum Replies Date
A Review and Verification for Maintaining Software Software Quality Assurance 10
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Recurrent event analysis software (python) General Auditing Discussions 2
Y UL 1998 Standard: software classes Software Quality Assurance 0
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
I Form templates for software (iso9001) Document Control Systems, Procedures, Forms and Templates 0
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
S HIPAA-compliant monitoring software (advice needed) Hospitals, Clinics & other Health Care Providers 1
A Software bug fixes after shipping a product EU Medical Device Regulations 3
J Medical software Patient outcome Medical Information Technology, Medical Software and Health Informatics 2
F Grand Avenue Software, Q-Pulse or Qualio - which for a full eQMS? Medical Information Technology, Medical Software and Health Informatics 1
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Is my software an accessory? Telecommunication between HCP and patients EU Medical Device Regulations 10
K Verify Software Architecture - supporting interfaces between items IEC 62304 - Medical Device Software Life Cycle Processes 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7

Similar threads

Top Bottom