Certified Compliance Solutions, Inc. (CCS) has been a recognized industry leader for more than 10 years in software and process verification and validation for the medical device and pharmaceutical arenas. We have assisted over 200 clients in meeting QSR and FDA compliance.

We are your full service solution to design control, software validation, and software development. We provide support from custom medical device software development to independent testing and 510(k) submission services. Our company has been hired by the FDA Head-quarters to provide Software training for FDA investigators! Read the letter the FDA sent to Daniel P. Olivier, president of Certified Compliance Solutions.

Our experience and expertise ensure that you not only receive quality services but also full compliance with current FDA and European Community regulations. We take the mystery out of regulatory requirements for medical devices. Let CCS support you in your next software development project to enhance productivity and reduce compliance concerns.

We are also experts in the following areas:

• 21 CFR part 11 compliance (Electronic Records/Signatures)
• Safety Risk Assessment & Management
• Manufacturing process and software validation for both Medical Device and Pharmaceutical companies
• Regulatory Submissions and Support
• Audit Services for:
• FDA QSR requirements
• ISO 9001 compliance
• Supplier
• In house training

Learn how CCS' expertise in FDA and ISO regulatory requirements for design controls and software validation can augment your internal staff. We offer proven procedures that reduce compliance risk for a cost effective price. We provide free estimates and references. Call us today, 858-675-8200, and discuss with us your needs.