EMMAIntl

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Are You Practicing GDPs?

8 years ago • 1781 Views

The Client X Project

7 years ago • 405 Views

The New EU MDR and What You Need to Know

4 years ago • 120 Views

Navigating the US FDA for Combination Products

4 years ago • 204 Views

Compliance and Competitive Advantage - The Intelligent QMS

4 years ago • 37 Views

Managing Risk with EQMS

4 years ago • 39 Views

Integration OF Human Factors Engineering with Design Controls

4 years ago • 30 Views

Medical Device Product Development

4 years ago • 181 Views

Medical Device Manufacturing and Product Quality Program

4 years ago • 37 Views

COVID-19 and the FDA: What Every Manufacturing Company Needs to Know

4 years ago • 62 Views

Building a QMS for Your SaMD

4 years ago • 204 Views

GDPR in the Healthcare Industry

4 years ago • 85 Views

Building a QMS for Your SaMD Part II

3 years ago • 109 Views

Regulatory 101 for Medical Device Start Ups

3 years ago • 34 Views

AI and ML in SAMD

3 years ago • 140 Views

Quality Function Deployment (QFD) for Design Controls

4 years ago • 112 Views

Medical Device Single Audit Program (MDSAP)

4 years ago • 177 Views

FDA to Align with ISO 13485:2016

3 years ago • 25 Views

FDA’s Digital Software Pre-Certification Program

3 years ago • 33 Views

FDA the Gold Standard for Medical Device Safety

3 years ago • 14 Views

What Your Saliva Reveals About You: Direct-to-Consumer Genetic Tests

3 years ago • 5 Views

FDA’s Efforts to Respond to the Ebola Virus

3 years ago • 17 Views

What the Government Shutdown Means to the Med Device Industry?

3 years ago • 5 Views

A No-Deal Brexit and the Impact on Medical Devices

3 years ago • 35 Views

Transitioning to The EU MDR? Do You Have a PRRC Yet?

3 years ago • 6 Views

Revamping De Novo for the Digital World?

3 years ago • 9 Views

The Unique Device Identification System for Class I and Unclassified Devices

3 years ago • 13 Views

Your 2019 Wish List!

3 years ago • 7 Views

FDA’s 510(k) Pilot Programs

3 years ago • 16 Views

A Brief Analysis of Medical Device Quality System Enforcement Actions [2015 -2017]

3 years ago • 10 Views

UK’s Preparation for a No Deal Brexit

3 years ago • 21 Views

Initial Premarket Assurance of Safety and Effectiveness for AI/ML Medical Devices

3 years ago • 13 Views

Quality Systems and Good Machine Learning Practices

3 years ago • 31 Views

Modification after Initial Review and Transparency and Real-World Performance Monitoring

3 years ago • 7 Views

Application of Risk Management to Medical Devices in the EU

3 years ago • 29 Views

FDA’s Approach to SaMD Modifications

3 years ago • 20 Views

Power of Vaccines

3 years ago • 7 Views

How FDA Regulates 3D Printed Medical Devices

3 years ago • 35 Views

Artificial Intelligence & Machine Learning Technologies

3 years ago • 19 Views

FDA’s Updated Guidance on Cybersecurity

3 years ago • 38 Views

The EU MDR Deadline … Are We Really Ready?

3 years ago • 8 Views

The End of the Longest Government Shutdown

3 years ago • 4 Views

Use of Genetic Databases to Advance Diagnostic Test Development

3 years ago • 18 Views

FDA Approved vs FDA Cleared

3 years ago • 13 Views

Clinical Lactation Studies: Considerations for Study Design

3 years ago • 23 Views

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