Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF)

S

sance

#1
#1
Hello all,

I little background before I ask question: My company had PMS procedure in place (by the way I want to thank to forum memebers for their great input in my learning curve that resulted in a great procedure). Our products are very simple (dressings). There was no MDR report ever. Last year (2013) we performed literature search (comparison between our products and other competitors products). Through annual management review all complaints, CAPAs, internal audits, risk management of each product, etc. were reviewed. I have compiled all of that clinical literature data in the clinical evaluation report. Our auditor was satisfied with procedure and suggested to add also adverse events or trade shows reports etc. However, this year I am a little bit confused.

Do we have to do PMCF (Post-Market Clinical Follow-up) now? Is PMCF done only for compiling clinical studies of the human subjects (in hospitals or clinics) or does it include literature search? As I'm reading guidelines and regulations, my understanding is that we for sure have to have PMS in place and based on the results of the PMS (for example new hazard is identified) then we have to do PMCF. Please correct me if I am wrong. Any help will be greatly appreciated. Thank you all in advance!:confused:
 
Download Free White Paper
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W 6.1.3 Compliance obligations b) - problem with understanding ISO 14001:2015 Specific Discussions 0
PQ Systems Understanding Capability and Control Charts Series Using SQCpack Software 0
M ISO 12944 Understanding the thickness guidlines Oil and Gas Industry Standards and Regulations 0
N Help with understanding Process Controls Manufacturing and Related Processes 7
Q Understanding "free movement" for CE-marked products EU Medical Device Regulations 2
D High level understanding of EUDAMED EU Medical Device Regulations 3
A 60601-1 understanding of stationary device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Surface Roughness understanding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 34
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
M Understanding Versions of Collateral and Particular Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1

Similar threads

Top Bottom