Welcome to Product and Educational Services LLC ("PES") website. PES has been in business since 1988 helping medical device and pharmaceutical companies establish and implement quality systems, validate software applications, and write 510k Premarket Notifications.
PES is registered with the FDA as a manufacturer of medical devices and in 2008 we received our first 510K Clearance to market a line of sterile eye spheres and conformers. PES also handles, stores, and distributes medical devices for an orthopedic manufacturer and for a company conducting clinical trials on a variety of products giving us experience across the board from design and development to storage and distribution.
PES’ strength is its knowledge and experience in ensuring compliance with applicable Good Manufacturing Practices (cGMP), Good Clinical Practices (cGCP), and Good Laboratory Practices (cGLP). We have helped companies obtain ISO 13485 Certification and CE Marking for their products and we have established FDA compliant Quality Management Systems for many other companies. Please contact us for assistance with your Quality Assurance and Regulatoiry Affairs programs.
Product and Educational Services LLC