Services (Global Leadership & SME Consulting)

Bachem Americas, Inc.
American Peptide, Inc.
Colfax Corporation
DJO Global, Inc.
Brickell Biotech, Inc.
Vical, Inc.
Absolute-DSI, Inc.​

Quality Assurance

Regulatory Affairs

EU MDR 2017/745
EU IVDR 2017/746
Premarket Notifications (510k's)
Technical Files (EU and AU)
Design Dossiers (EU)
Onboarding EAR's and IOR's
IFU, Packaging and Label design
Ad/Promo, Websites, Apps

Client Organizations, Education, and Accreditations

Abbott Rapid Diagnostics (ARDX), Inc.
Ameditech, Inc.
Immunalysis, Inc.
eScreen, Inc.​
Ortho Development Corporation
Philips, Inc.
Spectranetics, Inc.​

Michael B. Vader, M.S., RAC

US FDA (cGMP, cGLP, cGDP)
ISO 13485, and ISO 9001
Design Controls (Design V&V)
Lean Six Sigma
CAPA, SCAR, NCR
AER/Medical Device Reporting 
Recall/FSCA, and Stock Recovery
Post-Market Surveillance

Accreditations:

Engineering

Johnson & Johnson (JNJ), Inc.
DePuy Synthes, Inc.
The Production Board (TPB), Inc.
HealthMyne, Inc.
OthoPediatrics Corp.
MD Orthopaedics, Inc

Vision, Strategy, and Direction
Strengthening Infrastructure
Building Culture/Mentoring
Negotiation/Consensus building
Capital & Asset Allocation
Financial Planning
Key Performance Indicators (KPI's)
Recruiting top talent​

Present and Former Experience:

Education:

Global Leadership

IEC 60601, and IEC 62304
DFMEA, and PFMEA
Design Controls (Full Lifecycle)
Usability/Human Factors
V&V, and Test Method Validation 
IQ/OQ/PQ (Equip., & Software)
ISO 14971, and ISO 24971
3D Modeling, and Prototyping

Abbott, Inc.
Alere North America, Inc.
Inverness Medical, Inc.
Biosite Diagnostics, Inc.
Innovacon, Inc.
Quidel Corporation, Inc.
Sequenom Genomics, Inc.​

Regulatory Affairs Certificate (RAC) in Devices
Regulatory Affairs Professionals Society (RAPS)
www.RAPS.org 

​Six Sigma Black Belt (SSBB)
Project Management Institute, Inc.
www.PMI.org 

​Certificate of Achievement in Mathematics, Natural Science, and Computer Science
Grossmont College
College of Sciences
www.Grossmont.edu 

Master of Science (M.S.) Degree in Regulatory Science
Johns Hopkins University (JHU)
Krieger School of Arts and Sciences
www.JHU.edu 

Bachelor of Arts (B.A.) Degree in Physics
San Diego State University (SDSU)
College of Sciences
www.SDSU.edu 

​Associate of Science (A.S.) Degree in Physics
Grossmont College
College of Sciences
www.Grossmont.edu 

Associate of Science (A.S.) Degree in Mathematics, Natural Science, and Computer Science
Grossmont College
College of Sciences
www.Grossmont.edu ​