Services & Solutions
Is your Quality Assessment process inadequate in identifying significant quality and regulatory issues? Is your audit function chronically behind schedule? E.M.M.A. International Consulting Group, Inc. will fix your audit process, train your auditors, and help you adhere to your audit schedule. Additionally, we provide complete independent audits for all functions and requirements. We will provide an effective audit to all ISO, EU, QSR, CMDR, GMP, GLP, and/or GCP standards. A final report will be provided that not only meets your regulatory requirements, but will identify your systemic quality problems.
We have the experience in providing the support needed to obtain your ISO 9001, ISO 13485, ISO 15189, and TS 16949 certifications. If you are looking to market devices overseas, we can help you select a recognized Notified Body and prepare submissions for EC certification and product CE marking. We will also prepare submissions and assist in JPAL (Japan) and CMDI (China) registration. We also have a proven track record of expertise in Canadian Medical Device Regulations (CMDR), and Canadian Medical Devices Conformity Assessment Scheme (CMDCAS), PMDA, ARGMD and other international directives.
Customer Complaint Handling
The effectiveness of a complaint system is not only a major focus of FDA scrutiny, it is a sometimes-neglected or under-utilized source of potential revenue. Addressing customer complaints, fixing design or production issues, and identifying trends to prevent small customer problems from becoming major sources of dissatisfaction all contribute to your bottom line. E.M.M.A. International Consulting Group, Inc. can help you make your complaint handling system more effective and thereby increase your profits.
Corrective and Preventive Action (CAPA) process – Is your system inadequate? Is it too complex to be effective? Are you overwhelmed with CAPA problems that are overdue for corrective action? Do your CAPA teams have trouble finding the true root causes of problems? These issues result in more FDA Warning Letter findings than any others. We will develop, improve, and simplify CAPA to make it the effective, value-added process you need it to be.
E.M.M.A. International Consulting Group will work with your R&D staff to develop practical and effective design requirements, validations, and Device Master Records (DMR) as required by FDA. We will help you produce adequately safe and reliable products through utilization of valuable Failure Mode and Effects Analyses (FMEA) and Fault Tree Analyses (FTA). Additionally, E.M.M.A. International Consulting Group, Inc. can bring your design and manufacturing risk management processes up to ISO 14971 standards.
E.M.M.A. International Consulting Group, Inc. will work with your organization to assist in the remediation efforts due to FDA compliance issues, warning letters or consent decrees, utilizing a risk-based strategic approach.
This is a relatively new focus of FDA, and an area that has been neglected by many healthcare companies. We have the expertise to implement supplier qualification and approval/disapproval processes, including a supplier assessment process. Let E.M.M.A. International Consulting Group, Inc. conduct your supplier audits for you. We can fulfill this regulatory requirement and provide valuable information concerning the quality and reliability of your suppliers and their products.
We will train your staff in the appropriate QSR, GMP, GLP, GDP, and/or GCP requirements. Are you having a problem meeting the new employee training or annual re-training requirements for your staff? Let us put you back into compliance.
Lean Six Sigma Deployment
The successful deployment of a Lean Six Sigma program requires leadership commitment. Our team of consultants will work with your leadership team to ensure their full engagement and support. E.M.M.A. International Consulting Group, Inc. can not only train your staff in Lean/Six Sigma principles, we will take the lead in managing and facilitating Lean/Six Sigma projects to make immediate improvements and cost savings, and help instill continuous improvement into your company’s culture. We believe that all meaningful and lasting change comes from a “grassroots” effort within the company, rather than a grand “whiz-bang” program that usually has a short life span.
Quality System Development
The heart of E.M.M.A. International Consulting Group, Inc. Our consultants have a deep passion for developing and building quality systems. Our consultants work with organizations to provide the best possible customizable solutions. Not only do our quality systems satisfy regulatory requirements, but they are of world class excellence.
Quality and Regulatory Review
E.M.M.A. International offers a unique service to our clients who would like an expert to review their quality and regulatory needs, and provide a foundational strategy on their next steps.