We need a QMS: file-based templates or software

bob44

Starting to get Involved
#1
We are a pre-revenue medical device, US-based company with about 6 months to go till finishing pivotal clinical study for eventual PMA submission.
We assume we will be bought out by a bigger fish before we have to commercialize the device.

We need a QMS and are struggling with buying Word/Excel file-based templates for < $1K or spending > $2.5K for software/web based system.

Any suggestions from those who may know better than our guessing?

TIA!
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
We are a pre-revenue medical device, US-based company with about 6 months to go till finishing pivotal clinical study for eventual PMA submission.
We assume we will be bought out by a bigger fish before we have to commercialize the device.

We need a QMS and are struggling with buying Word/Excel file-based templates for < $1K or spending > $2.5K for software/web based system.

Any suggestions from those who may know better than our guessing?

TIA!
The canned documents that I've seen are not any good. You'd be better off developing your own.
 

bob44

Starting to get Involved
#3
Al,
So what to use as a guide/help to "develop your own" advice?
No one has any experience with QMS in our group.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Al,
So what to use as a guide/help to "develop your own" advice?
No one has any experience with QMS in our group.
My opinion is to hire someone in the medical device industry as a consultant to help you make wise decisions and guide you.

You say
No one has any experience with QMS in our group.
is a pretty scary thought. Getting an experienced consultant in the medical device industry could cost a bit, but long term could not only save you money but also be important to the success of your company.
 

bob44

Starting to get Involved
#6
We do have paid consultants to assist with content but for the type of system we are constructing: file-based or "cloud/software" based?
 

indubioush

Quite Involved in Discussions
#7
I agree with everything said about getting someone to help you. When you say "file-based," I'll assume you mean paper-based. Definitely go with paper. It is able be changed easily and you won't have to deal with software validation. Paper is way cheaper. The paper system will also force you to understand quality system requirements. In my opinion, people who don't understand quality system requirements won't be able to put good information into the software system. It has the potential to be a big mess.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#8
Personally I wouldn't put anything into the cloud, but that's me. I would think your consultant would give you appropriate guidance for your specific situation/scenario. Obviously they are not. That makes me question your consultant(s) capability, or whether your contract is so bare that it's not part of their responsibilities.

To me this is also pretty scary:
We assume we will be bought out by a bigger fish before we have to commercialize the device.
 
Thread starter Similar threads Forum Replies Date
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
M Need help on QMS Development in an AS9100C certified organization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
D Need advice in streamlining antiquated 21 CFR 820 compliant QMS Quality Manager and Management Related Issues 2
C How long does AS9100 QMS need to be in place before the Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
F Who and how many Approvers do I need for QMS Documents? Document Control Systems, Procedures, Forms and Templates 10
L Do I need a QMS and what do I need to ensure my QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Need to Train Management for Management buy-in for the QMS Training - Internal, External, Online and Distance Learning 6
T How to determine the correct QMS I need Misc. Quality Assurance and Business Systems Related Topics 3
C What does the average employee need to know about the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P Does your finance department need QMS documentation? Document Control Systems, Procedures, Forms and Templates 8
D No Changes in the QMS since last audit - Need to Re-audit for coming Surveillance? Internal Auditing 17
T Distribution of documents on an internet based QMS - I need to vent!!! Document Control Systems, Procedures, Forms and Templates 11
A Need help with creating useful, interesting and good internal web site about QMS!!! After Work and Weekend Discussion Topics 5
J New to TS 16949... "Shalls" do not need to be addressed in the QMS? IATF 16949 - Automotive Quality Systems Standard 11
S QMS Implementation - Weird Situation - Need Suggstions Quality Management System (QMS) Manuals 2
D Do I need metrics (or numbers) assigned to every QMS process I have identified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Need brief and clear description of ISO 9001 QMS quality standard - Student report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom