Preparation of Documents defining Design Input

J

judy yang

#1
hello,i am prepare for a product's quality documents.

i have no idea of the following item.is there anyone can help me?

"documents difining the design input requirements"

thank you!
 
Elsmar Forum Sponsor
S

SteveK

#2
Re: Prepare for design input documents

hello,i am prepare for a product's quality documents.

i have no idea of the following item.is there anyone can help me?

"documents difining the design input requirements"

thank you!
Judy,

You should have a procedure (SOP) in place which follows the standard requirements, for example in mine in the Design & Development Inputs section states:

The design input requirements (listed below) must be clearly defined and documented to preclude the possibility of any deviations. The design input will include:
•Customer/Market requirements and specifications, and where applicable, information from similar designs.
•Tolerances as specified.
•Conformance to regulations and legislative requirements, which will be documented to the requirements of 93/42/EEC Council Directive and the relative product regulatory standards.
•Results of risk management analysis performed.
•Evidence of the product functional, performance, safety and reliability requirements according to intended use under normal conditions.
•Material specifications, cost, lead times, special tooling, manufacturing processes, installation and servicing.
•Relevant documentation, which will be verified by the Product & Design Manager and/or the Quality Assurance Manager.

i.e. it covers section 7.3.2

I hope this helps.

Steve
 
J

judy yang

#3
Re: Prepare for design input documents

hello,Steve
i got your point.we have procedure valid to iso13485.for a special product's design input documents,is that mean :following regular's requirement e.g iso13485 ,give a detail statement of how the parameter was shape,or just proved parameter is ok?
thank you for your help;)
 
I

ivanraqa

#4
Hi Judy, if I understood you question, the design input ensures that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. Basically, what are the requirements wanted for the device to have?
 
G

greatJohn

#6
I just wanted to piggy back of Judy's question. Are there standards for tolerances, tests needed, specs or others for specific device group(i.e. orthopedic implants, dental implants...)?

Also, how much does it cost to prepare design input documents? I know that it varies based on the underlying concept, but what kind of ranges are we talking about here?
 
J

judy yang

#7
thank you for your advices! from your words,i have got the answer.my understanding like that:for a medical company,we have procedure file following iso13485.so,according to this procedure,every step(e.g design planning)will bring some documents.so this defining design input document was birth with design going on.content of this document was from related standard,guests' requirement,similar product of our company.
is that right:eek:
 

Marcelo

Inactive Registered Visitor
#8
The worst error i see regarding product development of medical devices is that companies that do not know product development used the CONTROLS defined by ISO 13485 as the product development process.

You shpuld have a product development process (using a product development model that fits your company), this process would have all the documentation related to product development. Then, it´s only a matter of linking the documents you should already have to the CONTROL requirements of ISO 13485.
 
J

judy yang

#9
hello,mmantunes.thank for your advice;)
we already have controls according to iso13485.so the following thing is link matters:)
 

Phil Huber

Inactive Registered Visitor
#10
SteveK,
Thank you!
Your simple statement helped me to identify our design input. It too is a simple document titled "New Product Introduction Request Form" and lists customer specific requirements, material, etc. plus marketing information.

I am new to this company and am performing a Gap Analysis as we speak. Identification of this document allowed me to find a few missing elements.

I Love the Cove, what a great exchange of information!:agree1:
Phil Huber
 
Thread starter Similar threads Forum Replies Date
B Remote IATF 16949 audit preparation General Auditing Discussions 10
Q AS 9120 exam Preparation Tips AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
Ooi Yew Jin Customer E audit preparation Quality Manager and Management Related Issues 2
P ASQ Certified Biomedical Auditor (CBA) Certification Preparation 2019 ASQ - American Society for Quality 3
C Raw material Mixing / Preparation for clean room class C injection molding Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S ISO 9001:2015 & ISO 14001 Re-Certification Audit Preparation ISO 14001:2015 Specific Discussions 8
I IATF16949 Audit Preparation, Need "searchable" ANPQP 3.1 or latest IATF 16949 - Automotive Quality Systems Standard 1
andika_untoro ASQ CQE Exam Group for Dec 2019 / Jan 2020 Preparation ASQ - American Society for Quality 18
J ASQ Chicago Training Institute - If any of you are interesting in teaching ASQ Certification preparation ASQ - American Society for Quality 1
A CTD (Common Technical Document) for a Topical Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
E RAC EU preparation aids - Tips on how to prepare for RAC EU exam Professional Certifications and Degrees 2
L Preparation for ISO 9001:2015 - Required Document Revisions Document Control Systems, Procedures, Forms and Templates 10
T Is a new edition of the IEC 60601 in preparation for 2019 (Amendment 2)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Marc Homework and Examination Preparation Help Policy Elsmar Cove Forum ToS and Forum Policies 1
D AS9100 Audit Preparation Costs and Hours AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Q ISO 9001 Survelliance Audit Preparation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Cost of DMF Type III preparation and submission Other US Medical Device Regulations 1
D What is a reasonable consulting fee for preparation of a complete traditional 510k? Consultants and Consulting 11
M What CQA Preparation Material helped you to pass the exam? Career and Occupation Discussions 6
Q Requirements and suggestions for ISO/TS 16949 Internal Auditor Preparation IATF 16949 - Automotive Quality Systems Standard 1
B OCP 11g 1Z0-053 Exam Preparation Professional Certifications and Degrees 1
B API Q1 & Monogram Preparation Oil and Gas Industry Standards and Regulations 19
C What are the best preparation materials for ASQ CSSBB? Professional Certifications and Degrees 2
P RAC (Regulatory Affairs Certification) US Spring 2013 Preparation Study Group Professional Certifications and Degrees 3
P Acquire formal USFDA Inspector for USFDA Inspection Preparation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Advice for preparation of ADOA and POA audits - What are the most critical points? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
optomist1 Interview Preparation for Quality Supervisory Position - TS16949 Environment Career and Occupation Discussions 24
R Information on RAC US Test Preparation Material Training - Internal, External, Online and Distance Learning 1
S What is the role of "Reviewer" and "Approver" in the preparation of procedures? Document Control Systems, Procedures, Forms and Templates 9
A FDA Inspection Preparation Hints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
G Preparation Work for Internal Audit before they Audit a Area Internal Auditing 2
K Guidance on Preparation for EASA Certification wanted EASA and JAA Aviation Standards and Requirements 4
M CQE Preparation - Classes offered by ASQ or QC Group Professional Certifications and Degrees 9
C Preparation for Product Validation Protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
R Inspection types A, B AND C used in FMEA Preparation FMEA and Control Plans 3
M ASQ CQA Exam June 4, 2011 - Best resource for preparation Professional Certifications and Degrees 19
K AS 9100 Rev C - Risk Management Procedure and Template Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q 5 Tips for ISO 9001 Certification Preparation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N Putting SOPs in place in preparation for ISO certification - where to start? Service Industry Specific Topics 5
P Entry Level Quality Engineer Interview Preparation/Advice? Career and Occupation Discussions 23
S ISO 17025 Quality Manual Preparation ISO 17025 related Discussions 7
Q ASQ CQM (Certified Quality Manager)/OE Certification Exam Preparation Materials Professional Certifications and Degrees 3
R Preparation for AS9100B conversion to AS9100C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
jkuil Clean Room Class for Aseptic Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
G How important is using the current QCI study primer revision for preparation Professional Certifications and Degrees 1
S City & Guilds Quality Assurance exam preparation (June) - Guidance needed Professional Certifications and Degrees 6
M Best Preparation Material for the CQE in June Professional Certifications and Degrees 3
N Preparation time for the 'spring' RAC Exam - sufficient time? Professional Certifications and Degrees 1
S CQM/OE Certification - May 2010 - Exam preparation tips and actual exam experience Professional Certifications and Degrees 6

Similar threads

Top Bottom