Certified Compliance Solutions
Certified Compliance Solutions (CCS) is a full-service provider specializing in design control, software validation, and software development for the medical device and pharmaceutical industries. Established in 1990, CCS offers expert regulatory and quality compliance services, including consulting, audits, training, and support for FDA and ISO standards. Their mission is to help companies achieve compliance while optimizing quality and productivity, leveraging industry best practices and proven methodologies.
Industries
Nr. of Employees
small (1-50)
Certified Compliance Solutions
San Diego, California, United States, North America
Products
Design control and 510(k) guidance flyer
A published guidance flyer simplifying design control documentation and a risk‑based approach to prepare essential content for 510(k) submissions.
Quality systems procedure templates flyer
Flyer describing established QMS procedure templates aligned to FDA QSR and ISO 13485 to accelerate QMS implementation.
Cybersecurity support flyer
Documentation outlining services for identifying vulnerabilities, implementing controls, testing, and providing a Secure Product Development Framework in accordance with regulatory guidance.
Process and non‑product software validation flyer
Flyer describing procedures, templates, and checklists for validating manufacturing processes and quality support software to maintain a defensible validated state.
Risk management support flyer
Flyer describing processes, templates and checklists to maintain defensible risk management files and integrate risk management into technical and regulatory filings.
EU MDR and ISO 13485 implementation checklist
Checklist and sample material to support implementation of EU MDR GSPR and ISO 13485 processes.
Design control and 510(k) guidance flyer
A published guidance flyer simplifying design control documentation and a risk‑based approach to prepare essential content for 510(k) submissions.
Quality systems procedure templates flyer
Flyer describing established QMS procedure templates aligned to FDA QSR and ISO 13485 to accelerate QMS implementation.
Cybersecurity support flyer
Documentation outlining services for identifying vulnerabilities, implementing controls, testing, and providing a Secure Product Development Framework in accordance with regulatory guidance.
Process and non‑product software validation flyer
Flyer describing procedures, templates, and checklists for validating manufacturing processes and quality support software to maintain a defensible validated state.
Risk management support flyer
Flyer describing processes, templates and checklists to maintain defensible risk management files and integrate risk management into technical and regulatory filings.
EU MDR and ISO 13485 implementation checklist
Checklist and sample material to support implementation of EU MDR GSPR and ISO 13485 processes.
Services
Conduct of quality management and regulatory audits, including MDSAP and ISO 13485 assessments, with practical recommendations and support for audit responses.
Pre‑inspection mock audits, pre‑inspection training, and on‑site support during inspections to reduce inspectional observations and guide inspector interactions.
Guidance and preparation for premarket submissions (510(k), PMA, BLA) including pre‑submission planning, submission packaging, and long‑term filing strategies to minimize review delays.
Tailoring and implementation of QMS procedures using established templates aligned to FDA and ISO requirements to accelerate QMS deployment.
Support for design control documentation, traceability, software lifecycle requirements, and risk‑based specification development.
Custom medical device software development and independent software validation, including lifecycle testing and documentation.
Conduct of quality management and regulatory audits, including MDSAP and ISO 13485 assessments, with practical recommendations and support for audit responses.
Pre‑inspection mock audits, pre‑inspection training, and on‑site support during inspections to reduce inspectional observations and guide inspector interactions.
Guidance and preparation for premarket submissions (510(k), PMA, BLA) including pre‑submission planning, submission packaging, and long‑term filing strategies to minimize review delays.
Tailoring and implementation of QMS procedures using established templates aligned to FDA and ISO requirements to accelerate QMS deployment.
Support for design control documentation, traceability, software lifecycle requirements, and risk‑based specification development.
Custom medical device software development and independent software validation, including lifecycle testing and documentation.
Expertise Areas
- Regulatory compliance for medical devices
- Quality management system (QMS) implementation
- Regulatory submission strategy and preparation (510(k), PMA, BLA)
- Medical device software development and validation
Key Technologies
- ISO 13485 quality management systems
- 21 CFR Part 820 (Quality System Regulation)
- EU Medical Device Regulation (EU MDR) technical documentation
- Medical Device Single Audit Program (MDSAP)