Representative First Last Date February 4 2015 Location Misc Conference Room Management Review Agenda Roll Call of Attendees 561 Suitability of Quality Policy 53e Status of Quality Objectives ID: 653391
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Slide1
Management Review
Management Representative: First Last
Date:
February
4
, 2015
Location:
Misc.
Conference RoomSlide2
Management Review Agenda
Roll Call of Attendees (5.6.1)Suitability of Quality Policy (5.3e)
Status of Quality Objectives (
5.4.1)
Results
of Audits
: 1st
party, 2nd party
, 3rd
party
and FDA inspections (5.6.2a
)
Customer Feedback (5.6.2b)
Process Performance
(5.6.2c)
Product
Conformity (5.6.2c
)
Supplier Quality Performance (Clause 8.4)
Status of
Corrective and Preventive Actions
(5.6.2d)
Follow-up Actions from Previous Management Reviews (5.6.2e)
Changes that Could Affect the QMS (5.6.2f)
Recommendations for Improvement (5.6.2g)
New or Revised Regulatory Requirements (5.6.2h
)
Risk Management Process Effectiveness (3.2 in EN ISO 14971:2012
)
Overall Quality System Effectiveness (5.1)
Improvements Needed to Maintain QMS Effectiveness (5.6.3a)
Improvement of Product Related to Customer Requirements (5.6.3b)
Resource Needs (5.6.3c
)Slide3
Roll Call of Attendees (5.6.1)Slide4
Suitability of Quality Policy (5.3e)Slide5
Status of Quality Objectives (5.4.1)Slide6
Results of Audits (5.6.2a)Slide7
Customer Feedback (5.6.2b)Slide8
Process Performance (5.6.2c)Slide9
Product Conformity (5.6.2c)Slide10
Supplier Quality Performance (Clause 8.4)Slide11
Status of Corrective and Preventive Actions (5.6.2d)Slide12
Follow-up Actions from Previous Management Reviews (5.6.2e)Slide13
Changes that Could Affect the QMS (5.6.2f)Slide14
Recommendations for Improvement (5.6.2g)Slide15
Previous Changes Not Fully Implemented by FDA (5.6.2h)
UDI Final Rule – Implementation Deadlines started in 2014 and end in 2017; http://bit.ly/UDI-ComplianceDates; this will be globally compatible
21 CFR 803 was updated to require electronic submission of MDRs by manufacturers; implementation deadline is August 14, 2015;
http://bit.ly/udpated-21CFR803Slide16
10 New FDA Final Guidance (5.6.2h)
New Final Guidance Released in Q4:Doc # 1810, Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff
Doc # 1685,
Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration
Staff
Doc # 1694,
Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA
Staff
Doc # 1768,
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration
Staff
Doc # 1400052,
Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power
Morcellators
- Guidance for Industry and Food and Drug Administration StaffSlide17
10 New FDA Final Guidance (5.6.2h)
More New Final Guidance Released in Q4:Doc # 1750, Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff
Doc # 1763,
Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration
Staff
Doc # 1400019,
Class II Special Controls Guideline: Nucleic
Acid-Based
In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration
Staff
Doc # 1819,
Distinguishing Medical Device Recalls from Medical Device Enhancements - Guidance for Industry and Food and Drug Administration
Staff
Doc # 1825,
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration StaffSlide18
5 New Draft FDA Guidance (5.6.2h)
New Draft Guidance Released in Q4:Doc # 1400045, Radiation Biodosimetry Devices - Draft Guidance for Industry and Food and Drug Administration
Staff
Doc # 1808,
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration
Staff
Doc # 1787,
Flow
Cytometric
Devices - Draft Guidance for Industry and Food and Drug Administration
Staff
Doc # 1739,
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (
LDTs)
Doc # 1738,
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs
)Slide19
US New & Revised Regulatory Requirements (5.6.2h)
FDA released FY 2015 proposed guidance development list on 1/8/2015 - http://bit.ly/FY2015-Proposed-FDA-guidanceNote: this slide deck is not product or company-specific. Therefore, you should also review updates specific to your product(s) at the following links:
Recognized standards (
http://bit.ly/Recognized-Consensus-Standards
),
Device classifications (
http://bit.ly/ProductClassification
), and
Total Product Lifecycle (TPLC) database (
http://bit.ly/FDA-TPLC
).Slide20
EU New & Revised Regulatory Requirements (5.6.2h)
MEDDEV 2.12/1 rev. 8; Guidelines on a Medical Devices Vigilance System - most recent revision to EU Guidance documents in January 2013
Rev 8 forms for vigilance were dropped and Rev 7 is still valid
No new consensus statements or interpretive documents
The Notified Body Recommendation Group (NBRG) released a draft of a consensus paper related to the Z annexes for EN ISO 14971:2012 on June 25 of last year. You can download the draft document at the following
link:
http
://
bit.ly/Consensus-Draft-14971
. The
draft is still not approved by the
NBRG
.Slide21
EU New & Revised Regulatory Requirements (5.6.2h)
Proposed EU Medical Device Regulations (EMDR) were modified by ENVI Committee and Parliament, but waiting for EU Council to provide input; new EMDR expected in 2016 with 3-year transition
Europa website recently changed many pages; More frequent review of updates may be needed in 2015
Events Calendar of EU Commission meetings
was posted:
http://
bit.ly/EUEvents2015Slide22
Canadian New & Revised Regulatory Requirements (5.6.2h)
The CMDR indicates that it is current to December 22, 2014; however, the last amendment was December 16, 2011 (i.e., no significant changes).New draft regulation, October 20, 2014: Draft Guidance Document - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses, Decorative Contact Lenses, and Menstrual
Tampons
Fees are update on April 1, 2015
MDSAP Pilot has begun. Health Canada intends to replace CMDCAS program with MDSAP in 2017. Only recognized registrars are eligible for MDSAP pilot.Slide23
Risk Management Process Effectiveness (ISO 14971)Slide24
Overall QMS Effectiveness (5.1)Slide25
Improvements Needed to Maintain QMS Effectiveness (5.6.3a)Slide26
Improvement of Product Related to Customer Requirements (5.6.3b)Slide27
Resource Needs (5.6.3c)