CSS:
CSS:
CCS provides consulting services to medical device and pharmaceutical companies to assure compliance while optimizing quality and productivity.
CCS has a proven track record of assisting companies with logical compliance since it was established in 1990 and has provided quality and regulatory consulting services for over 200 medical device and pharmaceutical companies.
We have been helping companies align their Quality Management Systems to meet both the FDA’s and Notified Bodies requirements.
Our integrated approach helps companies be prepared for the ever-changing regulatory landscape.
Capabilities:
Capabilities:
- MDSAP and Quality System Audits
- ISO Audit Preparation and Support
- CE Mark Technical File Submission Support
- EU MDR Support
- FDA 510(k) & PMA Submission Support
- FDA Inspection Preparation and Support
- Design Controls Documentation and Support
- Supplier Quality Audits and Qualification
Approach:
Approach:
We emphasize practical solutions that provide business value as well as assure compliance. Our trained personnel use established procedures, templates, checklists, and guidelines that have proven to be successful with leaders in the medical device and pharmaceutical industries.
Experience:
Experience:
- More than 30 years as consulting company in medical device and pharmaceutical industries
- Conduct of over 300 quality system audits
- Support for medical device companies in over 80 FDA inspections and ISO Audits
- Support for over 150 510(k) and PMA submissions
- Sponsor of over 20 quality system seminars
- Establishment of FDA and ISO compliant quality systems for over 50 companies