Sandler, Travis & Rosenberg can assist clients with medical device compliance issues by providing the following services.
- Counsel on all phases of the product development cycle, including pre-clinical activities, clinical trials, application process, product maturity and post-market environment, including guidance on risk management and regulatory strategies to help bring products to market as quickly as possible.
- Preparation of pre-market applications (510(k)). Determination of appropriate device classification (class I, II or III) or existence of exemption status.
- Identification of predicate devices for substantial equivalence determination.
- Support in design processes and failure analysis, verification, or validation protocols in addition to required medical device reporting.
- Counsel sponsors, public and private institutions, Institutional Review Boards, clinical research organizations, site management organizations and principal investigators on various issues involving clinical research.
- Support in developing Federal Trade Commission-compliant advertising materials (print and Internet).
- Counseling clients on good manufacturing practices, labeling and advertising matters, conducting product recalls, responding to warning letters and managing FDA inspections.
- June 15, 2016
- April 22, 2016
- March 22, 2016
- October 27, 2015
- August 26, 2015
- August 19, 2015
- February 11, 2015
- February 9, 2015
- January 22, 2015
- February 17, 2014
- October 18, 2013
- October 4, 2013
- September 23, 2013
- September 9, 2013
- July 9, 2013
- April 5, 2013
News Alerts & Advisories
- September 12, 2016
- September 25, 2013STR Press Release