Insights

Best Practices in Successful Product Design Acquisition Integration

Orla Blount, Sr. Director of Business Development, Shital Patel, Chief Operating Officer & Sr. VP of Operations, and Maylin Truesdell, Director of Regulatory Affairs, of ECI led a plenary session at the AMD Summit 2024 on the value of pre-acquisition due diligence and post-acquisition gap assessments. Access the full recording here.

White Paper

Significant Change Within the Context on EU MDR

This White Paper summarizes the significant changes and the changes that could jeopardize valid Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) certificates for legacy devices leading to the necessity of applying for a MDR cert prior to the end of the transition period as set by the European Union (EU) Law. This paper also provides an overview summary of the recently updated guidance Medical Device Coordination Group (MDCG) document 2020-3 Rev 1 titled, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

LEARN MORE

Regulatory Affairs

Medical Devices

11/4/2024 14:09

White Paper

The Fundamentals of Medical Device Complaint Handling

The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. This white paper will help you comprehend and effectively handle your company’s complaints from their opening through the closing of the complaint.

LEARN MORE

Quality

Post Market Surveillance & Vigilance

Medical Devices

11/4/2024 14:09

White Paper

The Key to Interpretation for FDA Guidance

Guidance documents are prepared by Food and Drug Administration (FDA) staff to describe the Agency’s current thinking or policy on a particular Regulatory issue. This white paper provides recommendations for industry to consider when interpreting an FDA guidance document.

LEARN MORE

Regulatory Affairs

Medical Devices

11/4/2024 14:09

White Paper

The Regulatory Crux with Artificial Intelligence as a Medical Device

This white paper discusses the current regulatory state and highlights critical quality practices for AI medical products.

LEARN MORE

Regulatory Affairs

Medical Devices

11/4/2024 14:09

White Paper

What to Expect During an FDA Inspection and How to Prepare

It is imperative that a firm be ready for the FDA to enter their facilities to conduct an inspection at any reasonable time. This white paper explains to the medical device industry about what to expect from the FDA during an inspection and how to prepare for such an event. It also addresses what not to do during an FDA inspection.

LEARN MORE

Quality

Regulatory Compliance

Medical Devices

11/4/2024 14:09

White Paper

No results found

Featured

Best Practices in Successful Product Design Acquisition Integration

Posts

Significant Change Within the Context on EU MDR

The Fundamentals of Medical Device Complaint Handling

The Key to Interpretation for FDA Guidance

The Regulatory Crux with Artificial Intelligence as a Medical Device

What to Expect During an FDA Inspection and How to Prepare

ECI on LinkedIn & Twitter

Who We Serve

Our Reliable Solutions

Let Us Help

Insights

Featured

Best Practices in Successful Product Design Acquisition Integration

Posts

Type

Service

Industry

Significant Change Within the Context on EU MDR

The Fundamentals of Medical Device Complaint Handling

The Key to Interpretation for FDA Guidance

The Regulatory Crux with Artificial Intelligence as a Medical Device

What to Expect During an FDA Inspection and How to Prepare

ECI on LinkedIn & Twitter

Who We Serve

Our Reliable Solutions

Let Us Help