Introduction to the Medical IT, Medical software and Health Informatics forum

Marcelo

Inactive Registered Visitor
#1
Hello all

Welcome to the new forum under "medical" here on the Cove. The idea of this forum is to have a place, here in the Cove, to discuss subjects which are hot today and will be even hotter in the following years - the fields of medical information technology, medical software, health IT, and whichever name you might have heard (I could list another 2 or 6 different ones I've heard on the last few years). Although each term I cited can be linked to all or some parts of thius field, the main idea is the interaction of IT/software with healthcare.

There are a lot of activities in this field, and some of those (and which I myself am more involved into) are:

- the standardization works of ISO TC 215 - Health Informatics

- standards for medical device software and health software created by IEC 62 A / ISO TC 215 JWG 7 and IEC 62 A / ISO TC 210 groups

- a series of standards (80001 series) dealing with risk management of IT networks incorporating medical devices, created by IEC 62 A / ISO TC 215 JWG 7

- the works of a lot of institutions/associations/etc. such as HL7, IMIA, IEEE EMBS 11073, and a lot more.

This does not mean that the forum is only related to works of standardization on this area.

One importnt aspect right now is, differently from, for example, the medical device field, the medical IT/health informatics field is not that regulated (and the regulations nowadays are somewhat scattered) - and a lot of things are really blurring at the moment. However, due to the increasing concern with the subject, regulators are becoming aware of the possible need of regulatory enforcement actions (iphone health apps, anyone?). This forum will also come in handy, anticipating and providing ground for discussion of future regulations on the field.

So, please feel free to begin threads on related topics and ask the questions which, in fact, every one of us might have right now!
 
Elsmar Forum Sponsor
D

drpaige

#3
I am new to the Medical Device compliance arena.....I have been immersed in HIPAA/HITECH for many years. I am working with a company who is designing a variety of devices and software. I see many new programs available in the market. Is there a place to see if they have filed to check for SE?
Many thanks......
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I am new to the Medical Device compliance arena.....I have been immersed in HIPAA/HITECH for many years. I am working with a company who is designing a variety of devices and software. I see many new programs available in the market. Is there a place to see if they have filed to check for SE?
Many thanks......
Hello and welcome to the cove :bigwave:

By SE, you mean Substantial Equivalence (510k)?

If so, you could chech the FDA's 510k database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

This will return finalised submissions. I'm not aware of a submissions-in-progress DB that is publicly open, but the gap would typically be under 3-6 months.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
A Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software. IEC 62304 - Medical Device Software Life Cycle Processes 43
L Introduction of Compulsory Bar Coding of Medical Devices in the US? ISO 13485:2016 - Medical Device Quality Management Systems 19
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
SteveK MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
S New Product Introduction Procedure - NPI Document Control Systems, Procedures, Forms and Templates 1
V Design Transfer to production = New product introduction ?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E Does introduction of a new brochure require a 510K? US Food and Drug Administration (FDA) 7
K Auditing New Product Introduction Process General Auditing Discussions 21
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
A What should be the contents of the New Gage Introduction Form ? General Measurement Device and Calibration Topics 3
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
A Food Warehouse ISO 9001 Audit and Newbie Introduction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
J EC Certificate and European Market Introduction CE Marking (Conformité Européene) / CB Scheme 8
AnaMariaVR2 Pharma ?Quality by Design? (QbD): An Introduction, Process Development & Applications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P Introduction of SPC to the Supply Chain Statistical Analysis Tools, Techniques and SPC 18
M NPDI (New Product Development & Introduction) Examples needed Excel .xls Spreadsheet Templates and Tools 3
S Monozukuri Rules for NPI (New product Introduction) - Help to get Lean in Manufacturing and Service Industries 3
D Introduction Coffee Break and Water Cooler Discussions 4
V Introduction Imported Legacy Blogs 6
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M TPM Announcement Letter for TPM introduction in a organisation Lean in Manufacturing and Service Industries 3
U Introduction of SPC - Embarking on my first implementation for precision machining Statistical Analysis Tools, Techniques and SPC 11
A QMS Introduction - I have been asked to give a brief introduction of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B New Product Development and Introduction Manual Manufacturing and Related Processes 5
P Introduction & Latest version of AIAG Control Plan request IATF 16949 - Automotive Quality Systems Standard 3
Hershal Introduction to ANS/ISO/IEC 17025 and Z540 ISO 17025 related Discussions 2
Q Procedure for New Product Introduction (NPI) - Build to print shop Various Other Specifications, Standards, and related Requirements 6
S NPI (New Product Introduction) in Electronics Industries Document Control Systems, Procedures, Forms and Templates 10
Y NPI (New Product Introduction) Process Qualification System Required Document Control Systems, Procedures, Forms and Templates 8
G Introduction to TS 16949 - Excel Partnership Course Training - Internal, External, Online and Distance Learning 4
Manix TS16949 Training Requirements - Basic introduction to the standard vs. Lead Auditor Training - Internal, External, Online and Distance Learning 8
J Free Introduction Course - VBA (Visual Basic for Application) in Excel to make forms Excel .xls Spreadsheet Templates and Tools 10
C Definition NPI (New Product Introduction) Readiness - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
B Educating Employees - Introduction to what quality is all about ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Six Sigma .ppt or .doc Presentations - Awareness session or introduction wanted Training - Internal, External, Online and Distance Learning 17
A Design document - Seeking "New Product Introduction" manual example Design and Development of Products and Processes 7
K Games for training - Introduction to ISO 9001 for Upper Management Quality Manager and Management Related Issues 9
R Where can I get ISO 13485:2003 Introduction Training Videos Training - Internal, External, Online and Distance Learning 3
G Introduction of ISO/IEC17024:2003 in Australia General Auditing Discussions 3
D ISO 9001 Introduction and Training for Employees Training - Internal, External, Online and Distance Learning 36
D Fresh Coffee - An Introduction Coffee Break and Water Cooler Discussions 65
G When Do I Start FMEA? During project introduction? FMEA and Control Plans 5
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 0
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 0
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 0
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 2
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
G Accelerated stability of medical devices Other Medical Device Related Standards 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
Similar threads


















































Top Bottom