Regulatory

Helping you navigate the regulatory maze

At Thogus, we leverage our long history and our broad and deep background in collaborative innovation to our clients’ advantage. That’s especially true in the area of helping them navigate various regulatory requirements, which are constantly on the rise. We have decades of experience in some of the most heavily regulated sectors—such as medical devices and aviation—and every day we bring that experience to bear with new clients.

Here are just a few ways we help you navigate regulatory requirements:

Regulations & Validation.  Good Manufacturing Practices (GMP) is required when manufacturing medical devices. We steer you in the right direction when it comes to documentation, testing and quality assurance processes.  

FDA Approval Process. Our professionals assist clients in the highly specialized task of compiling forms for government approval of new products, including 510(k) submissions for formal FDA market clearance of new products. We help clients determine:

• device classification (Class I, II or III)
• exemption status
• PMA (Premarket Approval Application) Requirement

Lead-Free Requirements. Restriction of Hazardous Substances, or RoHS directives are on the rise, especially in the healthcare arena and for goods being exported. We help manufacturers find lead-free solutions.

BPA-Free Materials. Clients in the food and beverage industry often need molded products that use BPA-free (bisphenol A) materials. We also routinely work with other technical specifications sanctioned by the FDA and the National Science Foundation.