Medical Device CRO

Monitoring
Auditing
Training
Consulting

Home
Our Team
Services
Careers
About
Resources
Contact
Blog

Subscribe via E-mail

Your email:

Most Recent

Inept Clinical Trial Endpoints Can Cost Billions
Medical Device Industry Impacted by Hurricane Sandy
IRB Reporting Compliance - Whose Job is it?
Did You Miss it?
Top 10: Cleveland Clinic Medical Innovations
The Cost-Saving Power of Study Evidence
GCP… What Does it Mean?
Should THIS be the Next Global Priority?
Conducting a Well-Controlled Clinical Study When Clinical Data is Required
Affordable Care Act: Impacting America’s Leadership?

Browse by Category

2.3% Medical Device (1)
2012 Medival Innovation Summit (1)
21 CFR § 50.25(c) (1)
21 CFR 312 (1)
21 CFR 50.20 (1)
21 CFR 54 (1)
21 CFR 56 (2)
21 CFR 56.113 (1)
21 CFR 812 (2)
21 CFR 812.110 (1)
21 CFR 812.140 (1)
21 CFR 812.140(a) (1)
21 CFR Part 56 (2)
45 CFR 46 (1)
510(k) (14)
510(k) Loophole (1)
A Call for Change (1)
Acronyms (1)
ACRP (1)
AdvaMed (3)
Affordable Care Act (1)
ALCOA (2)
Alexey Bersenev (1)
Amy Siegel (1)
and Cosmetic Act of 1938 (1)
Assent (1)
Audit (1)
Auditing Services (1)
AxioMed (1)
Benefit-Risk Determination (1)
BIMO (1)
BioEnterprise (2)
Bioscience (1)
brandy smith (1)
CAPA (1)
Cardinal Health (1)
Carl Heneghan (1)
Carmen R. Gonzales (1)
cell therapy products (1)
Cell Therapy Trials (1)
Centralized Monitoring (1)
CFR Part 50 (1)
Charlie Chie (1)
Checklist (1)
Children in Clinical Research (1)
Choosing a CRO (1)
Cleveland (1)
Cleveland Clinic (1)
Clinica Research (1)
Clinical Communications (1)
Clinical Data (2)
Clinical Data Requirements (1)
Clinical Drug Data (1)
Clinical Investigator (1)
Clinical Research (16)
Clinical Research Coordinator (2)
Clinical Research Organization (1)
Clinical Research Trials (1)
Clinical Studies (3)
Clinical Trial (2)
Clinical Trial Documentation (1)
Clinical Trial Endpoints (1)
Clinical Trial Enrollment (1)
Clinical Trial Loophole (1)
Clinical Trial Monitoring (1)
Clinical Trial Volunteer (1)
Clinical Trials (10)
ClinPage (1)
Code of Federal Regulations (1)
combination products (1)
compliance (1)
Concerns (1)
Conflict of Interest (2)
Congressmen Edward Markey (1)
Content Management (1)
Cook Medical (1)
Coordinators (1)
Corrective Actions (1)
Corrective and Preventive Actions (1)
Corruption (1)
Cost-Savings (1)
CRA Retention (1)
CRO (3)
Dateline (1)
de novo classification (1)
De Novo Process (1)
Declaration of Helsinki (1)
Derycz Scientific (1)
Device Accountability (1)
Device Classification (1)
Device Compliance (1)
Device Quality (1)
Device Recall Reports (1)
Device Reviews (1)
Direct Communication (1)
D-Mass (1)
Document Your Work (1)
Documentation in Clinical Research (1)
Dr. Andrew von Eschenbach (1)
Dr. Andrew von Eschenback (1)
Dr. Harvey Arbit (1)
Draft Guidance (1)
Drug (1)
Drugs versus Devices (1)
Ed Markey (1)
Edgewood Arsenal Experiments (1)
Electronic Regulatory Compliance (1)
EMA (1)
Emerging Markets (1)
Emergo Group (1)
eNewsletter (1)
EU (1)
EU Regulatory System (1)
European Medicines Agency (EMA) (1)
FAIR Shake (1)
FAIR Shake technique (1)
FAIR Shake Training Technique (1)
FAIR Shake™ Training Method (1)
Faster FDA Device Approvals (1)
FDA (75)
FDA Audit Responses (1)
FDA BIMO inspection (1)
FDA Enforcement Reports (1)
FDA Guidance (2)
FDA Safety and Innovation Act (1)
FDA Security Plan (1)
FDA Warning Letters (2)
FDA Website (1)
FDA's Center for Devices and Radiological Heal (1)
Federal Register (1)
Federal Regulations (2)
Financial Disclosure (1)
Foreign Corruption Practices Act (1)
Form 483 (1)
Former Pre-IDE Program (1)
Fuld & Company (1)
Global Clinical Trials (1)
Global Harminzation Task Force (1)
Global Priority (1)
Going Green (1)
Gold Medal (1)
Good Clinical Practice (6)
Good Documentation Practices (1)
Good Monintor (1)
Greg Bonfiglio (1)
Greg Davis (1)
Growth Opportunity (1)
Healing Innovations (1)
Health Wellness (1)
Healthcare Startups (1)
High-Risk Devices (1)
HIPAA (1)
House of Representatives (1)
Human Subject Protection (1)
humanitarian device exemption (1)
Hurricane Sandy (1)
ICH GCP (1)
ICH GCP E6 4.8.3 (1)
IMARC Research (3)
IMARC Research Whitepaper (1)
Impact Profits (1)
Implantable Devices (1)
Improper Consent (1)
Improve Site Compliance (1)
Infographic (2)
Informed Consent (7)
Informed Consent Process (1)
Innovation (1)
Innovation Pathway 2.0 (1)
Institute of Medicine (1)
Integrated EDC/EHR System (1)
International Organization for Standardization (1)
Investigator Oversight (1)
IRB (6)
IRB Oversight (2)
IRB Reporting Compliance (1)
Is Your Trial Complex (1)
JD (1)
Joe Hage (1)
john lehmann (14)
Journal of Clinical Research Best Practices (1)
Kem Hawins (1)
Ketek Trial (1)
Kips Bay Medical (1)
life science (1)
LinkedIn (1)
LinkedIn Group (1)
Literacy (1)
Margaret Hamburg (3)
MassDevice (2)
md+di (6)
MDUFA (1)
Med Tech Companies (1)
MedCelerate (1)
MedCity News (2)
MedCityNews (1)
Medical Device (17)
Medical Device Clinical Trial (1)
Medical Device Companies (4)
Medical Device CRO (4)
Medical Device Development (1)
Medical Device Firms (1)
Medical Device Generics (1)
Medical Device Industry (5)
Medical Device Maker; Post-Market Studies (1)
Medical Device Manufacturers (1)
Medical Device Oversight (1)
Medical Device Patient Safety Act (1)
medical device patients (1)
Medical Device Professionals (1)
Medical Device Recalls (1)
Medical Device Review Guidelines (1)
Medical Device Submissions (1)
Medical Device Tax (3)
Medical Device User Fee & Modernization Act (1)
Medical Device Users Fees (1)
Medical Devices (3)
Medical Devices Group (1)
MedTech (1)
Med-tech (1)
MedTech Doom and Gloom (1)
Medtech Industry (1)
Med-Tech Industry Acronyms (1)
MedTech Job Growth (1)
Merrill Goozner (1)
Michael Santalucia (1)
Modernize Clinical Trials (1)
Monitor (4)
Monitoring (3)
Monitors (4)
Muscular Dystrophy Association (1)
National Database (1)
New England Journal of Medicine (2)
New FDA Draft Guidance (1)
New FDA Guidance (2)
New Symptom (1)
New York Times (1)
nick woods (1)
Non-English Speaking Subjects (1)
Non-Signficant Risk (1)
notes-to-file (1)
Nuremberg Code (1)
office of combination products (1)
Office of Device Evaluation (1)
Office of Information and Regulatory Affairs (1)
Ohio (2)
OMTEC 2012 Conference (1)
Onsite Monitoring (1)
ORTHOWORLD (2)
Outsourcing (1)
Outsurcing IRBs (1)
Pathway to Global Product Safety and Quality (1)
Patients (1)
PhD (1)
Plain Writing Act for Regulations of 2012 (1)
PMA (1)
Postmarket Surveillance Plan (1)
Postmarketing Surveillance System (1)
Preclinical Communications Strategies (1)
Pre-IDE Meeting (1)
Premarket Approval Application (1)
Premarket Approval Applications (1)
Pre-Submission Program (1)
PricewaterhouseCoopers (1)
Principal Investigator Oversight (2)
Pros and Cons (1)
Protection of Human Subjects (1)
Protocol Waiver (1)
Public Citizens (1)
Quality in Device Trials (1)
RAPS (1)
Reason Patients Withdraw (1)
Recruitment (1)
Refuse to Accept Policy (1)
Refuse to Accept Policy for 510(k)s (1)
Regulation Renovation (1)
Regulations (4)
Regulatory Binder (1)
Regulatory Environment in Europe (1)
Regulatory Reform Act of 2012 (1)
Regulatory Science (1)
Regulatory Strategy (1)
Regulatory System (1)
Relationship (1)
Rep. Edward Markey (1)
Research Coordinator (1)
Research Professionals (1)
Research Volunteer (1)
REU Associates (1)
Review/Approval Time-Lines (1)
Right Balance (1)
Risk Analysis (1)
Risk-Based Approach to Monitoring (1)
Risk-based Monintoring (1)
Risk-Based Monitoring (1)
Safety and Effectiveness (1)
Safety and Efficacy (1)
Sandra Maddock (4)
Save Money (1)
Sen. Jeff Merkley (1)
Senators (1)
Sentinel Assurance of Effective Devices of 2012 (1)
SET Device Act (1)
Shorten Time to Market (1)
Shortened Informed Consent Form (1)
Signficant Risk (1)
Site Compliance (1)
Site Enrollment (1)
social media (2)
Sponsor (2)
Sponsor-Investigator (1)
sponsor-investigators (1)
Standard Operating Procedures (1)
Standardizing Data Submission (1)
Steve Silverman (1)
Study Coordinator (1)
Study Evidence (1)
Subject (1)
Subject Protection (1)
technology solutions (2)
Texting (1)
The 2012 Ohio Bioscience Growth Report (1)
The Affordable Care Act (1)
The Biotechnology Industry Organization (1)
The Checklist Manifesto (1)
The FDA Reform Act (1)
The Food (1)
The Jobs Act (1)
The Medical Device User Fee Act Reauthorization (1)
The Nocebo Effect (1)
Threats to Medical Device Industry (1)
To-Do List (1)
Top 10 Medical Innovations (1)
Top 5 (1)
Top Five Trial Compliations (1)
Trial and Experimental Studies Transparency Act of (1)
Tufts Center for Study of Drug Development (1)
Tuskegee Syphilis Study (1)
U.S. Military (1)
UDI Provisions (1)
Understandable Language (1)
Union of Concerned Scientist (1)
Unique Device Identification (1)
United States (1)
US Government Accountability Office (1)
US Regulatory System (1)
User Deal (1)
Voluntary Audits (1)
Wall Street (1)
Warning Letter (1)
Warning Letters (4)
Well-Controlled Clinical Study (1)
Whitepaper (1)
World Health Organization (1)
World Medical Association (1)

Medical Device CRO Blog

Current Articles | RSS Feed

21 CFR 312 vs. 812: What’s the Difference?

Posted by John Lehmann on Wed, Sep 12, 2012 @ 06:47 AM

On Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials. Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

0 Comments Click here to read/write comments