MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Project Management and Compliance services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.
MAE Group can assist your company gain access in domestic and international markets through product registrations, selection of authorized representatives, local agents, and distributors all with pre-vetting services.
We can also work with you to maintain compliance and good standing with US import and export regulations to ensure your products reach their intended destination without major disruption.
In addition, through MAE Group’s strategic alliances we offer a complete suite of exceptional capabilities including business and market intelligence solutions, intellectual property strategy, research and development assessments as well as technology scouting and open innovation services.
MAE Group is ready to assist your company to expand its domestic and global reach and increase business revenues. No other service provider has the expertise and strategic alliances to provide your business with the competitive advantage that allows you to realize your business goals.
Premarket services include regulatory strategy development, project management, regulatory and team training, design, software and process verification and validation, biocompatibility review, sterilization validation review, internal audits, procedure development, labeling review and quality system management.
Submission services include dossier generation, liaison and negotiation with government agencies or in-country agents and securing clearances as well as U.S. Agent for foreign establishments.
Post-market services includes responding to FDA inspection observations (483) and warning letters, Notified Body observations, complaint and vigilance handling, Medical Device Reporting, recalls, adverse event management, advertising, off-label promotion and post–market surveillance.
Additional Compliance Services
The services include due diligence audits, EPA pesticide and pesticidal compliance, FIFRA regulation guidance, LVE and PMN applications and import and export compliance guidance.
MAE Group can bridge strategic and tactical boundaries and take concepts to successful market completion. Our ability to conceptualize, think strategically and understand the complex nature of regulatory affairs and compliance matters allows us to provide multiple solutions to complex issues.
MAE Group has the unique ability to understand the technical and business dichotomies and speak both technical and business languages as appropriate. We have extensive international travel experience and knowledgeable in many cultures from a business and personal perspective; we understand cross-cultural dynamics.
Product Experience Include:
– Cardiovascular – Arrhythmia detector and alarm (including ST segment measurement and alarm)
– Obstetrics/gynecology – Endometrial Ablation
– Gastrointestinal/urology – Gastrointestinal tube and accessories
– General and plastic surgery – Electrosurgical, cutting and coagulation
– Radiology devices – Remote controlled radionuclide applicator system
– Immunology – Albumin immunological test system
– Hematology – Blood and plasma warming device
– Microbiology – Influenza virus serological reagents
As well as other medical devices and in vitro diagnostic devices
– Combination products and companion diagnostics
– Instruments, Disposables and Assays
– Active Pharmaceutical Ingredients, excipients, drug precursors and cosmetics