After 8 years in the regulatory compliance consulting industry, we decided to alter direction. We continue to offer real-time solutions to medical device manufacturers. Now, we support regional, state and federal agencies in reaching a state of compliance by offering quality training, project management, strategic planning, and team support. Our consultants will work with you to address compliance requirements with multiple government agencies. Talk to us today about how we can support your growth, and profit margin.
Terrina Wilder entered the US Army from her home state of Wisconsin in 1988. Her military career as a Medical Specialist and Chemical Officer would ultimately open opportunities in industries such as primary healthcare, veterinary medicine, chemical manufacturing, drug development, and medical device manufacturing. Terrina has been in the Regulatory Affairs profession since 2000 and has been a certified RA professional since 2005. Her specialty has been global regulatory compliance for the medical device industry. TW Consulting and Associates was established in 2011 by Ms. Wilder and has served start-up, mid-size, and large medical device companies. TW Consulting and Associates has helped companies market their products in over 60 countries and strategically addresses worldwide regulatory compliance concerns. In her spare time, Terrina enjoys living in the North Texas area where she hikes, occasionally attends theatre productions, and has become a recent author.
We have effectively implemented strategic solutions to businesses that have experienced a recent merger, company rebranding, and post-market compliance challenges that had a positive ROI. In one case, a merger between two orthopedic companies experienced delays with their product re-registrations. Those delays were reduced from >70% to <5% in 5 months. Another medical device manufacturer launched a rebranding project that impacted multiple registration licenses and product inventory.
A strategic approach of managing the product inventory and collaborating with regulators for a feasible transition period allowed the company to successfully introduce the new branded products to a global market. Lastly, while x-ray systems were restricted from the domestic market under a FDA consent decree, market authorizations for remediated products of a medical device company were permitted for international markets in 50 non-US countries retaining loyal customers.