Global Radio Frequency Regulations for Medical Devices

M

murena

#1
Hi all.

Sometimes I struggle to grasp the regulatory requirements for devices that have some kind of wireless communication capability. Normally, those regulations are managed by non-medical device agencies (e.g. FCC in the US), and the requirements are too technical or confusing.

Does anyone know of a good summary or introduction to the regulory requirements for radio frequency approvals or a training course?

My perception is that currently many companies rely on consultants or testing houses to get the required approvals and licences, and there is very few capability being developed in-house for this topic.

Thank you.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Directory of Largest Global Certification Bodies (Accredited) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Sidney Vianna Informational IAF and ILAC to merge. A Global Accreditation mammoth? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
L Global distributor vigilance responsibility Medical Device and FDA Regulations and Standards News 14
J Getting training either from ASQ or from SAI Global - ISO 9001 Lead Auditor training Training - Internal, External, Online and Distance Learning 1
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
M Informational Fourth WHO Global Forum on Medical Devices REPORT Medical Device and FDA Regulations and Standards News 0
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
Q SAI Global Status as of July 2018 Registrars and Notified Bodies 2
S Regulatory Affairs Certification Exam (Global) Training - Internal, External, Online and Distance Learning 0
Sam Lazzara GS1 introduces Global Model Numbers for Medical Devices Other Medical Device Regulations World-Wide 2
T SAI Global - On sale again? (2017) Registrars and Notified Bodies 8
A Global Medical Device Quality Compliance Overview Presentation - Help Wanted Other Medical Device Regulations World-Wide 2
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
S Compliance to GADSL (Global Automotive Declarable Substance List) RoHS, REACH, ELV, IMDS and Restricted Substances 4
L Corporate Manual - Global Multi-Site ISO9001:2015 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc Definition GDSN - Global Data Synchronization Network Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition GTIN - Global Trade Item Number Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
D Global market registration requirements for IVD's Other Medical Device and Orthopedic Related Topics 2
B Global / Local Management Review - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Support Group for Global Quality, Regulatory, and Trade Compliance Professionals Other Medical Device Regulations World-Wide 0
T OES Global Results Drift Quality Manager and Management Related Issues 1
Q Global SCAR Software System Recommendations Quality Assurance and Compliance Software Tools and Solutions 2
W RAC EU/Global focus certification - Study Group for Spring 2015 Professional Certifications and Degrees 4
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
J GHTF (Global Harmonization Task Force) SG2 Guidance Documents EU Medical Device Regulations 3
C Should I get an Internal Auditor Certification of Exemplar Global / RABQSA? Internal Auditing 17
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
R SAI Global puts itself up for sale Registrars and Notified Bodies 11
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
L Certification for new company global engineering office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Ongoing Cpk and Global/Historical Data Statistical Analysis Tools, Techniques and SPC 7
R RABQSA is now Exemplar Global ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 23
D RAC Regulatory Affairs Spring 2014 EU or Global Exam Study Group Professional Certifications and Degrees 15
x-files Global Timeline Plan of IMS/QMS Activities for a Thermal Power Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P Global 8D Problem Solving Training Material Problem Solving, Root Cause Fault and Failure Analysis 1
P Global 8D Problem Solving Example Problem Solving, Root Cause Fault and Failure Analysis 5
V The ASQ Global State of Quality Book, Video, Blog and Web Site Reviews and Recommendations 2
AnaMariaVR2 Creating Global Giants from a Culture of Israeli Start-Ups Coffee Break and Water Cooler Discussions 0
S Global Document Control SOP example Document Control Systems, Procedures, Forms and Templates 4
P Anyone have experience with GLOBAL GAP (Global Good Agricultural Practices)?? US Food and Drug Administration (FDA) 5
MarilynJ6354 American Global Standards Virtual Registrar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Integrating Multiple HSEQ Systems into a Single Harmonised Global System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Call for an Expert Speaker @ QuEST Global Career and Occupation Discussions 7
S Structuring a QMS with a Global Company Quality Manager and Management Related Issues 4
Q Global Organisation Chart for the Quality Management Department Quality Manager and Management Related Issues 1
Similar threads


















































Top Bottom