Marketing, product and system requirements

#1
Hello,

We have recently started working on am SaMD product, and are having a hard time understanding the difference, hierarchy, and relationship between:
1) Marketing Requirments
2) Product Requirments
3) System Requirments
4) Software Requirments
5) Software Systems

Can someone suggest some relations, definitions, and/or related resources?

Thanks!
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Where did this list come from? There's no standard (required?) requirements structure. I think more typical is a hierarchy of User Needs (which can be marketing requirements) --> System Requirements (what we call "engineering's answer to the user needs") --> Software Requirements. Sometimes in complex systems, you can also break down system requirements by electrical, mechanical, labeling, etc. requirements.

User needs establish the basis for design validation and system requirements establish the basis for design verification. Software requirements establish the basis for software system testing but design verification and software system testing can be often merged.

(Oh, and don't forget Risk Controls. System risk controls should map to system requirements and software risk controls should map to software requirements.)

If you just have a SaMD then you probably don't need that intermediate "system" requirements. Software systems are the result of implementing the requirements.
 
#3
Thank Yodon. This was suggested by one of our employees.

This makes sense. So for a purse software device, like an SaMD, User needs -> Software requirements. Then we build a design for those software requirements which is the Software System/Item/Unit.

Thank you!
 
Thread starter Similar threads Forum Replies Date
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
P Requirements for Marketing Collateral for product distributed by another company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Medical Device Marketing vs. Placing Product on the Market EU Medical Device Regulations 8
L Product Specification trace back to the Customer Specification from Marketing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Product Name when Marketing four components as part of one product EU Medical Device Regulations 3
C Do EU policies dictate Nutritional Product Marketing Content? EU Medical Device Regulations 3
L Product Sales and Marketing Brochures - AS9100 Document Control Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
D Should Sales & Marketing be included in Product Realization? IATF 16949 - Automotive Quality Systems Standard 12
S Marketing Requirements vs Product Specifications ISO 13485:2016 - Medical Device Quality Management Systems 14
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
Sidney Vianna A young Steve Jobs take on Quality, Marketing & Business Processes. Coffee Break and Water Cooler Discussions 0
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
C FDA logo for marketing US Food and Drug Administration (FDA) 3
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Can a organization use a disclaimer "pending AS9100 Certification" in Marketing Information? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
T Marketing sticker for Medical Device outer box? EU Medical Device Regulations 8
D Not a SaMD - How to be submitted for marketing authorization in EU and USA CE Marking (Conformité Européene) / CB Scheme 5
J Literature Review (marketing etc) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
J Marketing and promotional materials - EU and MDR Specific EU Medical Device Regulations 13
J Control of Medical Device Marketing and Promotional Materials - EU regulation EU Medical Device Regulations 20
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M Translation requirements for marketing materials Other Medical Device Regulations World-Wide 1
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
S Marketing in one of the MDSAP countries ISO 13485:2016 - Medical Device Quality Management Systems 0
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
A ISO 9001:2015 Implementation for Marketing and Sales Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I FDA Marketing Claims - What is and isn't allowed Other US Medical Device Regulations 3
Wes Bucey Inspection - Done right, it can be a marketing advantage Manufacturing and Related Processes 3
D Japan Rules for Marketing Authorization Holders Japan Medical Device Regulations 1
J0anne MOC - Sterile Medical Device Marketing - India Other Medical Device Regulations World-Wide 1
S Auditing Sales and Marketing Processes and Technical Support Canada Medical Device Regulations 2
A Can anyone share as an example of SOP for Marketing Process ISO 13485:2016 - Medical Device Quality Management Systems 1
A SOP for Marketing Process for a Medical Devices Manufacturing Company wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
E Marketing and Sales involvement in 8.2.1 Customer Satisfaction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Use of non consensus ISO standards in Marketing Material 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
G More than one Marketing Authorization Holder (MAH) in Japan Japan Medical Device Regulations 2
J Declaration required for MD First Marketing in UK, DE, CH, BE and NL EU Medical Device Regulations 11
R Class II Medical Device - Marketing vs. Indication For Use (IFU) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Seeking help in writing marketing message Career and Occupation Discussions 12
M FDA Submission Consultancy - Registering and marketing our products in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T ISO 9001 for Advertising and Marketing Agencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Logo Marking for Marketing purpose - ISO 9001, ISO 14001 and OHSAS 18001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M ISO 13485 as a Marketing Tool for a Distribution Company ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom