Library

Recording Acceptance Sampling Results (June, 2013 – 2 Pages)

Lot Acceptance by Attributes in MIL STD 1916 (July, 2011 – 2 Pages)

Establishing the AQL (September, 2009 – 2 Pages)

Excel Spreadsheets Available (April, 2009 – 1 Page)

Attributes Acceptance Sampling_Understanding How it Works (April, 2009 – 72 Pages)

Three Views of the OC Curve (April, 2009 – 2 Pages)

Acceptance Sampling Exercises (April, 2009 – 1 Page)

Sequential Sampling Plans (January, 2009 – 3 Pages)

The OC Curve of Attribute Acceptance Plans (January, 2009 – 7 Pages)

MDIC Complaint Metric (March, 2017 – 2 Pages)

Process Metrics (March, 2009 – 6 Pages)

Corrective and Preventive Action Clearing up Confusion (September, 2011 – 2 Pages)

Complaints Servicing and FDA Reporting (November, 2009 – 119 Pages)

Preventive Action, Correction, and Corrective Action (May, 2009 – 63 Pages)

Ombu Comments on Notice of Information Collection for QSR (August, 2010 – 5 Pages)

Notice of Information Collection for QSR (August, 2010 – 6 Pages)

Review of Post Inspection Responses (August, 2009 – 3 Pages)

Critical Suppliers (November, 2016 – 2 Pages)

Supplier Quality Agreements for Medical Devices (May, 2010 – 85 Pages)

Supplier Quality Agreement Template ISO 9001 (January, 2010 – 15 Pages)

Supplier Quality Agreements ISO 9001 (January, 2010 – 86 Pages)

Medical Device Quality Agreement Template (November, 2009 – 17 Pages)

Documenting Changes Using the 510(k) Guidance (November, 2017 – 1 Page)

FD&CA Amended for Accessories (September, 2017 – 1 Page)

Use of FDA Approved (May, 2017 – 1 Page)

Article on Signatures, Initials, and Stamps (May, 2017 – 3 Pages)

Determining When a Device is 510(k) Exempt (January, 2017 – 2 Pages)

Understanding the Versions of Risk Management Standards (December, 2016 – 3 Pages)

Initial Importer (November, 2016 – 2 Pages)

Design Changes and 510(k) Submissions (October, 2016 – 4 Pages)

Out of Calibration Equipment (October, 2016 – 2 Pages)

Complaints and Reliability (October, 2016 – 2 Pages)

Complaints and Warranty Claims (October, 2016 – 5 Pages)

Essential Design Outputs (October, 2016 – 3 Pages)

MDR Exceptions and Variances (September, 2016 – 1 Page)

Record Retention for Device Manufacturers (September, 2016 – 5 Pages)

Setting Quality Objectives (July, 2015 – 6 Pages)

Setting the Medical Device Lifetime (May, 2013 – 3 Pages)

UDI Final Rule Timing (May, 2013 – 1 Page)

EU Publishes New List of Standards Harmonized to the MDD (September, 2012 – 2 Pages)

Excel Spreadsheet Validation with Multiple Versions (October, 2011 – 4 Pages)

Understanding Standards Harmonized to the MDD (September, 2011 – 2 Pages)

The Matrixx Case – Analysis by Dan O’Leary (June, 2011 – 8 Pages)

Changes to QSR (December, 2010 – 6 Pages)

Understanding “Product” in FDA’s QSR (December, 2010 – 3 Pages)

Process Validation for Medical Devices GxP Article (June, 2010 – 6 Pages)

Process Validation for Medical Devices (May, 2010 – 74 Pages)

Regulatory Requirements for Medical Device Calibration Programs (April, 2010 – 73 Pages)

Determining the Revision Level of QSR Sections (April, 2010 – 2 Pages)

Excel Spreadsheets and FDA Device Regulations (March, 2010 – 75 Pages)

Medical Device Classification (February, 2010 – 79 Pages)

Ombu Presentation at the FDA LDT Meeting (July, 2010 – 7 Pages)

European Commission Opens Consultation on the IVDD (July, 2010 – 9 Pages)

RoHS Q&A (September, 2010 – 3 Pages)

ALARP v AFAP (April, 2017 – 5 Pages)

State of the Art (December, 2016 – 1 Page)

Information for Safety in Risk Management (March, 2016 – 3 Pages)

Planning the Risk Management File Audit (April, 2015 – 8 Pages)

Cybersecurity Comments (July, 2013 – 2 Pages)

Understanding Risk Priority Numbers (June, 2011 – 2 Pages)

Medical Device Risk Management Using ISO 14971 (October, 2010 – 86 Pages)

Basic Statistical Tolerancing (November, 2010 – 5 Pages)

Selecting Discrete Sampling Distributions (December, 2011 – 3 Pages)

Usability Engineering Guidance Reference List (July, 2016 – 4 Pages)

Usability Engineering and the New Standard (September, 2015 – 6 Pages)

Warning latter on Calibration (May, 2017 – 2 Pages)

Accessories Warning Letter (March, 2017 – 2 Pages)

Warning Letter on Corrective and Preventive Action (February, 2017 – 2 Pages)

Warning Letter on Corrections and Removals (January, 2017 – 2 Pages)

Warning Letter on Software Validation (December, 2016 – 2 Pages)

Warning Letter on Equipment Maintenance (November, 2016 – 2 Pages)

Warning Letter on Supplier Selection and Evaluation (October, 2016 – 1 Page)

Warning Letter on Monitoring Validated Processes (October, 2016 – 2 Pages)

Warning Letter on MDRs (July, 2016 – 1 Page)

Warning Letter on Quality Audits (June, 2016 – 2 Pages)

Complaints and Warranty (May, 2016 – 2 Pages)

Quality System Record (April, 2016 – 2 Pages)

Environmental Controls (March, 2016 – 2 Pages)

Nonconforming Material Warning Letter (February, 2016 – 2 Pages)

ISO 13485:2016 Medical Device File (February, 2018 – 6 Pages)

Human Resources in ISO 13485-2016 (April, 2017 – 4 Pages)

Transition to ISO 13485-2016 (January, 2017 – 3 Pages)

Supply Chain Roles in ISO 13485:2016 (December, 2016 – 2 Pages)

Risk in ISO 13485:2016 (November, 2016 – 2 Pages)

Transition to ISO 13485 (October, 2016 – 3 Pages)

Supplier Management Comparative Analysis (March, 2016 – 11 Pages)

UDI in the MDR – Core Data Elements (November, 2016 – 4 Pages)

UDI in the MDR (November, 2016 – 5 Pages)

EU-MDR Transition Time Lines (May, 2017 – 3 Pages)

EU-MDR Risk Management System (March, 2017 – 2 Pages)

EU-MDR General Safety and Performance (March, 2017 – 3 Pages)

EU-MDR Person Responsible (March, 2017 – 2 Pages)

EU-MDR Economic Operators (March, 2017 – 3 Pages)

EU-MDR Classification and Conformity Assessment (March, 2017 – 2 Pages)

Improved Device Inspection Process (October, 2017 – 1 Page)

Risk Based Device Inspections (October, 2017 – 1 Page)

Inspection Authorization Extended (October, 2017 – 1 Page)

FD&CA Amended for Accessories (October, 2017 – 1 Page)

Facilitating International Harmonization (October, 2017 – 1 Page)

Medical Device Excise Tax (October, 2017 – 1 Page)

Medical Device Excise Tax Suspended (October, 2017 – 1 Page)

Preparing for eMDR (October, 2017 – 2 Pages)

Kits, Packaging Configurations, and Unit of Use (October, 2017 – 5 Pages)

Equipment Utilization Metrics (October, 2017 – 3 Pages)

Production Equipment Maintenance in QSR (October, 2017 – 5 Pages)

Identifying NBs and AOs (October, 2017 – 1 Page)

Documenting the Hazard Analysis Process (November, 2017 – 4 Pages)

Hazard Analysis and pFMEA (October, 2017 – 2 Pages)

Determining Training Effectiveness (October, 2017 – 1 Page)

MDSAP – Three Important Documents (November, 2017 – 2 Pages)

MDSAP – Purchasing Process (November, 2017 – 5 Pages)

Calculating MDSAP Audit Times (November, 2017 – 3 Pages)

C&R – A Short Overview (August, 2018 – 2 Pages)

Demonstration Tests – Attribute Sample Size (January, 2019 – 3 Pages)