FDA / QSR / European Directives CE Marking
The MOCG provides specialized consulting in technical FDA and ISO regulatory issues. We can guide your company through the maze of international and domestic regulations. Our experience includes working with medical device companies who offer their product(s) to European, Asian, Australian, South American and North American markets.
Our firm offers services to companies who require an expertise in medical device registrations, clinical trial management and access to contacts within the various global regulatory agencies.
We employ select medical device industry experts with many years’ experience within the FDA and international regulatory communities.
The MOCG provides efficient, effective regulatory support across the full spectrum of product design and development documentation through post-marketing compliance. From a high level of expertise to practical working solutions, our staff works with you to develop and implement global regulatory strategies, prepare submissions, plan testing or manage Agency communication. Whatever the task, our approach allows you to maintain project control while realizing the benefits of external support to provide a specific expertise or to manage workload during personnel shortages or project acceleration.
We provide expert counsel and support services to your company with:
- Reimbursement strategies for Europe and the US
- Project review and coordination
- Documentation of development, scale-up and production schema
- FDA QSR-21 CFR Part 820, ISO 9001 and ISO 13485
- All aspects of product and plant registration
- Preparation for FDA inspections
- Interaction at every level with regulatory agencies
- Pre-Clinical Studies (monitoring testing, data analysis and documented procedures)
- Clinical Studies ( monitoring case report forms [CFRs] )
- Premarket Notifications 510(k)
- Premarket Approval Applications (PMAs)
- Investigational Device Exemptions (IDEs)
- FDA Warning Letters
- Quality System Regulation (QSR) audits, training and procedure development
- Good Laboratory Practice (GLP) audits, training and procedure development
- International submissions
- Meetings with Ministry of Health Officials in European Community (EC) and European Free Trade Association countries
- Medical Devices Directive (MDD) systems evaluation
- CE Marking
- International Clinical Studies
- Working with major testing and Notified Body organizations