Regulatory Compliant Quality Management System - Bare Minimum

fialor

Involved In Discussions
#1
With the New EU MDR likely to come into effect May 2017 and implemented May 2020, businesses will continously be under more and more strain to streamline the compliance route, with regulatory professionals being challenged to become more pragramatic, and to think more along business lines.

With this in mind, what would you be your approach/strategy to setting up a regulatory compliant quality management system:
  • What are your basics?
  • How would you keep it pragmatic?
  • How do you approach the road to bringing your current regulatory structure to compliance?
 
Elsmar Forum Sponsor

Kronos147

Trusted Information Resource
#2
...what would you be your approach/strategy to setting up a regulatory compliant quality management system...
When you discuss your QMS, try saying "Management System" only. The 'Bare Minimum' approach is not effective. Do you want an ineffective Management System?

Make sure you look at what you do (Processes). Identify the requirements for that process. Review the process against the requirements. Find the gaps, fill in the gaps with easy things, like controlled checklists or work orders.

Don't re-invent the wheel! An effective internal audit should find the gaps, and once identified, these can be logged as Non Conformances and managed.


I suggest reading section 0.1 of the standard. The adoption of a Management System is a strategic decision. Failure to embrace the system cheats the organization of the benefits, and the culture turns to poo as everyone loathes to do the BS it takes to fool the auditor into letting you hang a piece of paper on the wall.


FWIW, not all auditors are like I was, but I was loath to write an NC if the company had already identified the issue and there was evidence of management.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#3
How do you approach the road to bringing your current regulatory structure to compliance?
While inefficiencies must always be corrected, an organization which's management wants to gamble with product regulatory compliance, within a context of diminishing goodwill by regulators and zero tolerance for failures, by society at large, is obviously uneducated in the science of assessing risks.

Failure to adequately address product regulatory compliance by denying proper resources is symptons of a very dysfunctional top management and it is just a matter of time until one of their risky bets come back to haunt them and everyone involved.
 
Thread starter Similar threads Forum Replies Date
V Countries without Formal Regulatory Approval Process Other Medical Device Regulations World-Wide 0
P Crucial Suppliers Listed on Regulatory Certificates EU Medical Device Regulations 3
N Brexit Combination Product Regulatory pathway for UK (MHRA). UK Medical Device Regulations 1
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A CE-Mark regulatory advice - US based Organization CE Marking (Conformité Européene) / CB Scheme 6
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
Justanobody PAD printing and meeting regulatory requirements Manufacturing and Related Processes 10
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
S Training for PRRC (person responsible for regulatory compliance) EU Medical Device Regulations 3
V Software license key regulatory requirements Medical Information Technology, Medical Software and Health Informatics 2
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
A Readiness for consultancy in Regulatory Affairs Consultants and Consulting 5
A A good Regulatory Affairs Manager EU Medical Device Regulations 15
M Regulatory compliance ISO 14001 ISO 14001:2015 Specific Discussions 5
E Which regulatory framework for an app-based study for research purposes? EU Medical Device Regulations 1
JoCam FSN for regulatory breach EU Medical Device Regulations 4
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 5 – What's the Rush? Other US Medical Device Regulations 0
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Watchcat REGULATORY WATCHCAT - New RA Cartoon Other US Medical Device Regulations 4
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 3 - Rearranging the Regs Other US Medical Device Regulations 0
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Watchcat REGULATORY WATCHCAT De novo Post Mortem 2 - Disclosure and Accountability Other US Medical Device Regulations 11
Watchcat REGULATORY WATCHCAT De novo Post Mortem 1 - Regulatory Religion Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De novo Post Mortem Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - RIP "Mini-PMA" Other US Medical Device Regulations 0
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 3
Watchcat REGULATORY WATCHCAT - His Grandmother's Technology Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Samples & Labeling Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Benefits and Risks Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Alternative Practices and Procedures Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Device Description Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Indications for Use Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments Other US Medical Device Regulations 2
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10

Similar threads

Top Bottom