Seeking material on the Construction Process in IEC 62304

D

didizione

Hi Guys.

I´m a master degree student in biomedical engineering. I would ask for you a little help to guide me about the material I want to study to understand about the construction process of IEC 62304. (some books, articles, etc).

Thanks in Advance,

Diogo Rispoli
 

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
I did just a quick search for the standard and it is software for medical devices.

My thought is get the standard itself first and read through it. Make sure you understand best practices, such as may be described in the TickIT guide and consider best practices as you read the standard.

Make sure whether you need to look at other influences, such as (but not necessarily limited to) the US Food and Drug Administration (FDA).
 

yodon

Leader
Super Moderator
Apologies for the delay in replying, been busy...

When you say "the construction process of 62304" what, exactly do you mean? As Hershal pointed out, 62304 is a standard for medical device software (life cycle). If you are asking about the build (compilation) and release process, the standards are going to be pretty generic since Integrated Development Environments (IDEs) manage most of those processes. You'll only see references to configuration identification, configuration management, etc.

A good resource, IMO, for the software life cycle (in general) is the Capability Maturity Model Integration (CMMI) from the Software Engineering Institute at Carnegie Mellon (I have no affiliation with them). It goes into good depth on software processes, including Configuration Management.

If that's not what you meant by the construction process, maybe clarify your needs.
 
Thread starter Similar threads Forum Replies Date
F Quality Awareness Sessions - Seeking Ideas and Presentation Material Quality Manager and Management Related Issues 4
X Seeking a handbook of MU or some material to start a self study Measurement Uncertainty (MU) 5
E ISO/TS16949 - Seeking refresher material as well as a motivation tool Training - Internal, External, Online and Distance Learning 1
B Seeking training and reference material for ISO 9001 aimed at IT Service Organization Training - Internal, External, Online and Distance Learning 3
CarolX Seeking training material on the use of micrometers and calipers Training - Internal, External, Online and Distance Learning 6
D AIAG's PPAP Reference Material - Seeking an electronics copy such as a .pdf file APQP and PPAP 4
I Seeking: Internal Audit Training Material - Practice Audits? Internal Auditing 14
A Seeking Ideas: Raw Material Storage Process Failure Modes FMEA and Control Plans 3
D Seeking help in validating a cleaning process. Manufacturing and Related Processes 5
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
M Seeking Consultant for Orthopedic Start Up company Other Medical Device and Orthopedic Related Topics 1
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 7
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
M Seeking advice regarding use of off-the-shelf (OTS) batteries Other Medical Device and Orthopedic Related Topics 4
A ISMS - Seeking VAPT Consultant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
silentmonkey Seeking efficient method to manage install base data Manufacturing and Related Processes 0
K Seeking ISO 13485 Registrar Recommendations Registrars and Notified Bodies 15
R Tapping problems - 3/8" hot roll pickled & oiled steel - seeking expertise Manufacturing and Related Processes 15
S Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Seeking for an example or a template of a Business Plan Service Industry Specific Topics 3
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
W Seeking Returned Merchandise Procedure Customer Complaints 1
QMMike New Trend of not seeking Official ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
T ISO 9001:2015 Training for Management Team in NM - Seeking Suggestions and Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Seeking Corrective Action Process Examples Nonconformance and Corrective Action 3
M AS9102 Training - Seeking third party agency that provides online AS9102 training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F Seeking Internship/Co-op Opportunities in Regulatory Affairs/QA/Clinical Domain (USA) Career and Occupation Discussions 4
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M Seeking opinion for ISO14001 team activity ISO 14001:2015 Specific Discussions 3
smryan Seeking good 2D barcode add-in for Excel Excel .xls Spreadsheet Templates and Tools 6
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
S Seeking examples of Nonconforming Materials Nonconformance and Corrective Action 5
S Seeking Quality Training for Quality Technicians Training - Internal, External, Online and Distance Learning 1
P Seeking Information on ISO 15504 - Information Technology Process Assessment Other ISO and International Standards and European Regulations 3
K Seeking NDT Training and Certifications Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Chennaiite Cause Analysis for Verification/Validation Failures - Seeking Opinions Problem Solving, Root Cause Fault and Failure Analysis 3
Q Seeking Examples of current ISO/TS 16949 Training Procedures IATF 16949 - Automotive Quality Systems Standard 2
Ron Rompen Seeking Test Lab which can do 1440 Hour Accelerated Weathering Characteristics Misc. Quality Assurance and Business Systems Related Topics 1
S Seeking Ballooned PFMEA and Control Plans for Training FMEA and Control Plans 4
B Seeking help in answering Australia Tax Withholding Declaration Coffee Break and Water Cooler Discussions 1
H ASQ CQE Exam Review Workshop - Seeking Volunteers! September 2013 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
N Seeking information on use of Byotrol Cleaning Chemicals in Pharma Industry Manufacturing and Related Processes 1
M Seeking input for a process-based quality management system training course ISO 13485:2016 - Medical Device Quality Management Systems 1
B Seeking help in writing marketing message Career and Occupation Discussions 12
B Seeking help in writing an audit report that can stand on the court Internal Auditing 6
S AAMI EC57 for ECG Medical Device - Seeking 3rd Party Test Laboratory US Food and Drug Administration (FDA) 5

Similar threads

Top Bottom