Welcome to Product and Educational Services LLC ("PES") website. PES has been in business since 1988 managing the quality systems, regulatory affairs, product design process, and distribution for small and medium sized medical device companies.
We are proud to announce Ortoway, LLC as a new client to the list of companies that rely on PES to provide supplimental management for their medical device company. Our ever expanding client list now includes:
ElectroCore, Morris Plains, NJ
EndoCore, Morris Plains, NJ
TherimmuneX, Doylestown, PA
In addition to our management services, PES itself 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’ 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. For further information please call or e-mail us at:
Telephone: 215 230 7515
E-Mail: pes@llcpes.com
Product and Educational Services LLC