Quest’s staff has years of experience helping organizations in the medical device industry. Our experience on Class I, II, and III devices has included full device design and development, support of device development, third party review, guidance on regulatory matters, guidance on adherence to quality system regulations, design and implementation of manufacturing fixtures including IQ/OQ and PQ. Quest has staff members with Regulatory Affairs Certification and a strong familiarity with the Quality System Regulations and ISO-13485. Areas where Quest has provided significant help and support of our client base include: