Can someone share a scrubbed version of Clinical Evaluation Plan (CEP)

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
L To share or not to share? Work distribution when someone goes on vacation Quality Manager and Management Related Issues 19
C Can someone share example of FAI Inspection Plan ? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
P Can someone share their experience with KFDA Inspection ? Other Medical Device Regulations World-Wide 30
Q Can someone share an Excel spreadsheet to measure Cpk or Cp values. Excel .xls Spreadsheet Templates and Tools 15
sardonyx DMR Index - Can someone share their Device Master Record Index structure or format? ISO 13485:2016 - Medical Device Quality Management Systems 15
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75
I Root Cause Analysis when someone simply stops performing a task? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Misbranding (by someone we've contracted with) in a Publication 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Q QI Macro Histogram - Can someone define *sorted data*? Capability, Accuracy and Stability - Processes, Machines, etc. 7
J Can someone help me get the UCL AND LCL for this problem? Statistical Analysis Tools, Techniques and SPC 2
A Can someone provide an example of a Product Safety Policy? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B What is the implication for someone who does not meet the 70% pass mark for QMS-Lead. Professional Certifications and Degrees 2
B Any future for someone working as Lead Quality right these days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Does someone has experience with a Supplier "Quality Watch" Supplier Quality Assurance and other Supplier Issues 3
R Full Time Internal Auditor - Where should I be looking for someone? Career and Occupation Discussions 15
M Medical Device Regulation in Mongolia - Can someone help? Other Medical Device and Orthopedic Related Topics 3
R Someone can help me with the Volkswagen LiOn and BeON-QPN System? Customer and Company Specific Requirements 3
S Do Work Instructions need to be approved by someone other than the author? Document Control Systems, Procedures, Forms and Templates 14
E Can someone help me with ISO 11539:1999 for contact lens classification? Other US Medical Device Regulations 2
Jim Wynne Someone better "diffuse" me before I asplode Coffee Break and Water Cooler Discussions 7
B Does someone use APQP for non automotive industrie? IATF 16949 - Automotive Quality Systems Standard 2
D En 62366:2006 - Can someone explain what EN 62366:2006 covers? Other ISO and International Standards and European Regulations 3
G I hope someone can give me a hand.. Various Other Specifications, Standards, and related Requirements 4
1 Career Advice - What someone with my qualifications can shoot for Career and Occupation Discussions 7
S Seek advice from someone that passed through NADCAP AC7102 and AC7101/3 Various Other Specifications, Standards, and related Requirements 6
M Total Variation Formula - Can someone provide a source for this formula Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
Q COQ (Cost of Quality) - Would someone review this doc and offer feedback? Benchmarking 10
K Internal Audit Guidelines for someone new Internal Auditing 12
P Device marketed by someone else & different name...is a 510(k) required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
J Can I get someone to help critique this manual? Quality Management System (QMS) Manuals 19
S Could someone tell me what are the results of a Gage R&R & how to interpret it? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
F Can someone to help to compare APQP and DMAIC? Six Sigma 10
C SPC presentation - How to convince someone to use SPC - Grind diameters Statistical Analysis Tools, Techniques and SPC 6
D Can Someone help me to understand....... Imported Legacy Blogs 3
Q REACH - Is it not the same as RoHS /IMDS? Can someone explain? RoHS, REACH, ELV, IMDS and Restricted Substances 1
J Sine Plate Charts - Someone lost the angle chart - Where can I get one? General Measurement Device and Calibration Topics 4
D Can someone take a look at my QM (Quality Manual)? Quality Management System (QMS) Manuals 7
C Can someone clarify "Resolution", "Discrimination" and "ndc"? General Measurement Device and Calibration Topics 4
A Internal Auditor - What is required to have someone qualified as an internal auditor? Other Medical Device and Orthopedic Related Topics 35
M Inspector Qualifications - Qualifying someone to be an inspector Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
ScottK Can someone clarify the Trans Fat thing? i.e. What = Bad Coffee Break and Water Cooler Discussions 8
GStough Looking for someone with experience in MDD, PPE, CMDR/CMDCAS regs General Auditing Discussions 1
H What I am trying to find is someone that remembers Memphis in the nineties Coffee Break and Water Cooler Discussions 10
ScottK Can someone explain the marketing behind this ad? Coffee Break and Water Cooler Discussions 21
M Escalation methods - Having to go over someone's head to address an issue Nonconformance and Corrective Action 6
E Synchronicity - Has someone lived an Event of Synchronicity? Coffee Break and Water Cooler Discussions 4
M Internal Auditing Independence Rule - Can someone provide a good interpretation Internal Auditing 20
samer How can someone create his own acceptance criteria ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Y Want to meet someone from big 3 in the supplier develop field to learn from Supplier Quality Assurance and other Supplier Issues 6
M Definition DCX - Can someone tell me what is DCX stands for? DaimlerChrysler? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Similar threads


















































Top Bottom