Early Research & Development - ISO 13485:2003 requirements Clarification

  • Thread starter TempusVernumProcella
  • Start date

Ronen E

Problem Solver
Staff member
Moderator
#31
(...) "chatter" about an idea between colleagues are required to be noted, so it's part of their system requirements and it's a non-conformance if they don't put <what ever it is> in their notebook.
Spooky.

I don't think this company would win any best-innovator prizes. definitely I wouldn't want to do R&D in such a company.

However, I'm already :deadhorse:
 
Elsmar Forum Sponsor
O

orangeisenergy

#32
Re: R&D 13485:2003 Clarification...

ISO 13485:2003 has ZERO requirements associated with the product research process, which is different and distinct from product design and development.
Can you explain the distinction between research & development and design & development? How do you categorize a project as being in research or design phase?
 

sagai

Quite Involved in Discussions
#33
It is easy!
In research phase engineers are relaxed, they recollection is that they have endless time and money.
In contrast in development phase engineering managers are running around like headless chicken due to sales and marketing terrorising them to sell the product quickly. :)
There could be more subtle explanation too, in essence I think this is the case.
Cheers
 
R

Reg Morrison

#34
Re: R&D 13485:2003 Clarification...

Can you explain the distinction between research & development and design & development? How do you categorize a project as being in research or design phase?
In my mind, pure research is an exercise to see if a new technology is feasible, if a specific performance parameter can be met, but THERE IS no product being made available commercially in the market place.

Product design happens when an organization HAS DECIDED that the end product will be placed in the market and will be offered commercially. There are implications to consumers and users if the product malfunctions. Certainly, there are projects that have to be scrapped during the product design phase, for many reasons.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#35
I worked in Academic research. If the IRB gave a non significant risk to the study the FDA was not involved. However, if the risk was higher and Human subjects were required then 21 CFR 820.30 Design Controls MUST be used.
 
Thread starter Similar threads Forum Replies Date
J EDMS for Very Early Drug Development (Research/Drug Discovery) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
P IEC 62304:2006 A1:2015 - Software from the early 1990s IEC 62304 - Medical Device Software Life Cycle Processes 4
M Informational FDA Panel: Too early to pull textured breast implants over cancer risk, need more data Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Interesting Discussion World wide energy demand will peak in the early 2030's Sustainability, Green Initiatives and Ecology 0
Q Is EN 55011:2009+A1:2010 is expiring in early 2019? Other ISO and International Standards and European Regulations 1
Marc Air Pollution in the Early 21st Century Coffee Break and Water Cooler Discussions 5
S Final FDA Guidance on IDEs for Early Feasibility Clinical Studies - 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Best Attribute Data Sampling Plan - Early Production Containment Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Tips 'n Tricks for getting a Job in the early 21st Century Career and Occupation Discussions 1
Q Reduced Device License Fee was rejected for being sent in too early Canada Medical Device Regulations 2
G ISO/DIS 14045 - Anyone have an early draft copy? Miscellaneous Environmental Standards and EMS Related Discussions 2
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
J Today it's 'Leave The Office Early' Day Career and Occupation Discussions 2
P Early versus Late delivery from suppliers - what's the acceptable ratio? Quality Tools, Improvement and Analysis 6
Stijloor ASQ Membership Renewal Request Comes Early - Will you renew?? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 35
M Risk Management - AS9100 revision C - Early advice please! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Juran is dead - Why the thread is closed so early? Philosophy, Gurus, Innovation and Evolution 2
Jim Wynne Never believe early news reports Coffee Break and Water Cooler Discussions 7
Marc When Flying, How early do you get to the airport? Travel - Hotels, Motels, Planes and Trains 25
Q Early Spring Cleaning - Finding Old Documents and Specifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Retiring Early or Never? Coffee Break and Water Cooler Discussions 65
T "Creative" ways to handle Early Production Containment Misc. Quality Assurance and Business Systems Related Topics 9
Marc GM in early talks to buy Chrysler World News 6
C Graph Choice For Monitoring DOA's (Dead On Arrival) and ELF's (Early Life Failures) Statistical Analysis Tools, Techniques and SPC 5
T AS9003 becoming obsolete as early as 2008??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D An Early Brush with Design of Experiments Design and Development of Products and Processes 7
M Aspect Indentification? Early stages of ISO 14001 implementation ISO 14001:2015 Specific Discussions 4
C Reasons for early termination of an audit? General Auditing Discussions 23
J GM's GP-12 Early Production Containment applicable to Tier 2 Suppliers? Customer and Company Specific Requirements 14
Marc BP Meets ISO 14001 Targets 8 Years Early Miscellaneous Environmental Standards and EMS Related Discussions 5
Marc Containment FMEA and GP-12 (GM procedure for early production containment) FMEA and Control Plans 9
Marc The Future of Quality - An Early Discussion Philosophy, Gurus, Innovation and Evolution 11
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
N Dataset for Academic Research - Infusion pump flow IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
T Control of R&D (Research and Development) Parts and Equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
R University Research Project - Management Review Management Review Meetings and related Processes 17

Similar threads

Top Bottom