Full Circle Consulting

EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.

Full Service

Full Circle Consulting

When

Product Development

Regulatory Submissions

Post Market Compliance

Manufacturing and Distribution

Why

Regulatory Strategy

Quality System Development

Quality System Implementation

EMMA OnDemand

Featured Services

COVID-19

EU MDR and IVDR

MDSAP

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Full Circle Consulting Resources

IEC 62304: Medical Device Software Life-Cycle Processes

IEC 62304: Medical Device Software Life-Cycle Processes

The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations as regulatory criteria for medical devices, these are referred to as recognized consensus standards [1]. Examples of some of the organizations that develop these standards are: International Organization for Standardization (ISO) standards, American Society for Testing and Materials (ASTM) standards, American National Standards Institute (ANSI) standards, International Electrotechnical Commission (IEC) standards, etc. The IEC is an organization that develops standards to standardize the electrical and electronic fields [2].
The 10 golden rules for GMP production: Part 2

The 10 golden rules for GMP production: Part 2

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures manufacturing products are consistently produced and controlled according to set quality standards. For pharmaceutical production this is especially important as the drugs manufactured are injected directly into patients. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 2 of a 2-part series and discusses the first 5 rules and why they are important.
The 10 Golden Rules for GMP Production – Part 1

The 10 Golden Rules for GMP Production – Part 1

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.
The eSTAR 510k

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability

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