Shop – Global Strategic Solutions

Clinical 1 hour (Introductory price)

Terri Guitierrez — Fri, 07 Aug 2020 17:36:06 +0000

I. Clinical Evaluations Plans & Reports
II. Performance Evaluation, Performance Studies, and Clinical Evidence Including Scientific Validity, Analytical Performance, & Performance Plans and Reports
III. Clinical Research – Development Plans, Statistics, Protocols & Reports, Informed Consents, Case Report Forms, Site Selection, Monitoring, Investigator Brochure, Auditing, and Public Postings
IV. Risk Management Including Product, Software, Clinical, and Cybersecurity. Also Root Cause, Usability, Human Factors, Complaints, Vigilance, and Field Actions
V. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF)
VI. Summary of Safety and Clinical Performance (SSCP) or Summary of Safety and Performance (SSP)
VII. PMS Reports
VIII. Periodic Safety Update Reports (PSURs)
IX. Surveys
X. Meta-Analysis
XI. Claims & Extended Indications
XII. Presentations and Publications

Free Consultation 15 minutes

Terri Guitierrez — Sun, 12 Jul 2020 19:16:07 +0000

Booking 15-minutes Free Consultation

Management Coaching / Interim Management 1 hour (Introductory price)

Terri Guitierrez — Sun, 12 Jul 2020 19:13:40 +0000

Booking 1 hour Management Coaching / Interim Management Capacity: 1-5

Strategic Market Entry 1 hour (Introductory price)

Terri Guitierrez — Mon, 06 Jul 2020 17:52:10 +0000

Booking 1 hour Strategic Market Entry Capacity: 1-5

Program / Project Management 1 hour (Introductory price)

Terri Guitierrez — Sun, 05 Jul 2020 19:35:16 +0000

Booking 1 hour Program / Project Management Capacity: 1-5

Regulatory (affairs, compliance, operations) 1 hour (Introductory price)

Terri Guitierrez — Sun, 05 Jul 2020 19:30:53 +0000

Booking 1 hour Consulting Regulatory Capacity: 1-5

Quality Management 1 hour (Introductory price)

Terri Guitierrez — Mon, 29 Jun 2020 16:36:30 +0000

Booking 1 hour Consulting Quality Management Capacity: 1-5