• Preparation of Regulatory Strategic Plans to Support new drug and medical device development


  • Direct participation on Client Design and Development Teams as the Lead Regulatory and/or Quality Engineering Resource


  • Drafting and Submission of Regulatory Application to U.S. FDA, E.U. Notified Bodies and comparable product registration documents worldwide

                  *   510(k) Pre-market Notifications for Class II Devices

                  *   Investigational Device Exemption (IDE) applications

                  *   Investigational New Drug (IND) applications
                  *   510(k) Pre-market Notifications for Class II Devices


  • .Design and implement quality system audits of medical device and biopharmaceutical manufacturers.


  • Assisting medical device manufacturers to implement quality control/assurance, regulatory affairs, document control, and complaint handling procedures.


  • Providing consulting services related to FDA medical device policies and procedures.  Providing recall advice and assistance as needed.


   FDA Regulatory Compliance Services ... 

when timing, expertise and budgets matter

 



Spotlight Focus on FDA  ....


Summit on Healthcare Technology In

Nonclinical Settings

Both FDA and the Medical Device industry

recognize that a paradigm shift is underway in the

way and location where healthcare will be

administered for chronically ill patients and those

who do not suffer from conditions or illnesses that require intensive 'in-hospital' medical care.    The impact on how medical devices will be regulated is huge.   Going forward device manufacturers and Design Control 'core team' members (e.g., Regulatory Affairs, Engineers and Quality) must take into account more than ever 'human factors' considerations, enhanced risk management assessment techniques and more empirical evidence that Class II and III devices can be used safely in a home setting.   


The Joint AAMI/FDA meeting held in Octover 2014 highlights the key issues that must be considered in this new development environment.   Read the Report to learn more....


The FDA Safety & Innovation Act (FDASIA) mandates that FDAfurther medical device innovation. To this end FDA has released a draft guidance on the process for approving applications for clinical investigations of medical devices, and is also using its authority under FDASIA to review "direct" de novo device submissions.

RegulatoryPro provides an array of services to FDA-regulated companies, including biopharmaceutical and medical device firms.   Our expertise is focused in the following areas: