Safety Risk Management support is one of our most sought after services
Expertise in safety risk management is becoming increasingly more critical to not only protect the safety of your customers but also to reduce compliance risk. We have established procedures, checklists, templates, and specifications for all required safety risk management specifications for FDA Design History Files and ISO Technical Files. Our risk analysis processes include a variety of formal techniques (FTA, FMEA, HACCP, and HAZOP) as well as review of industry safety mitigation practices and company product history. Through our support of hundreds of companies in safety risk management we have compiled a list of over 100 common system requirements that have been implemented to mitigate safety risks and to satisfy regulatory standards. Ask us, we will be happy to share this list with you.
Regulatory Consulting Support Services – we have significant experience in solving a wide range of regulatory challenges
We are expert in the FDA regulations and guidance documents especially in the area of design control compliance and software validation. We are also expert in ISO 13485 and can help with your international conformance needs. We provide third party quality system audits, and we have been recommended by the FDA for third party certification. We understand that thorough knowledge of the regulations, extensive audit experience (conducting and witnessing audits), wide exposure to industry solutions, and a proven history of interfacing with the FDA are essential to providing expert regulatory advice. We have the unique combination of knowledge and expertise in each of these areas. We can cite numerous examples where our strategies have helped companies avoid significant compliance actions.
Regulatory Submissions – we help companies not only file submissions but also define long range submission strategies
We know the most important objective of the submission process is to minimize questions and review cycles. We know how to structure the submission to reduce the number of documents to be submitted and to focus on key areas of reviewer questions. We have prepared over 100 510(k)s and supported over a dozen PMA submissions. We have supported Traditional 510(k)s, Special 510(k)s, and De Novo 510(k)s. Our support services include templates for all types of 510(k)s and PMAs that facilitate efficient review.
Engineering Process Compliance and Productivity Improvement – learn industry best practices
Many companies have requested our services to evaluate their development practices for not only compliance but also alignment with industry best practice. As a result we have prepared numerous improvement plans and inspection checklists that guide companies on a path to become best in class. In these consultation efforts we do not attempt to re-define your development practices but instead we tailor your practices to focus on the key elements that will eliminate regulatory risk while reducing development times and maintaining focus on product quality.
Training Programs, learn from our significant industry experience
We have conducted hundreds of training courses at open industry conferences as well as custom in-house training programs. Training courses include safety risk management, design controls, software validation and Part 11, managing regulatory audits, premarket submissions, and many more regulatory topics. Our courses are practical based on our extensive industry experience and include open questions and work shops that ensure that the lessons can be practically applied to your company.
Usability Testing
Human Factors in Engineering is receiving increased emphasis within the medical device community. Increased importance is being placed due to the growing number of incident reports and recalls involving usability errors. Ensure your product is not only safe & effective but easy to use by taking advantage of our experience and proven methods. Increase usability and ensure compliance with our templates and procedures.
|
Verification and Validation Services - we are recognized as industry leaders in design and process V&V
Verification and validation services is one of our core competencies. To reduce your financial risk we offer contracts with a not-to-exceed cost limit. We have provided V&V services for over 200 medical device and pharmaceutical manufacturers. Our use of risk based strategies combined with our established procedures, templates, specifications, and checklists not only enhance productivity, but also reduce compliance risk and increase the quality of the documents we prepare.
We know Part 11, understand the FDA’s current Part 11 focus
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. We have aided many companies in understanding the FDA’s current position on Part 11 and how to use risk based strategies to reduce compliance risk. Our checklists ensure focus on the systems that are most likely to be inspected by the FDA.
LIMS and ERP Validations – we can show you how risk based strategies can reduce implementation and maintenance costs
Validation of Laboratory Information Management Systems (LIMS) and Enterprise Resource Planning (ERP) systems consume significant resources and often do not result in the reduced compliance risk planned. We have performed validation of numerous LIMS and ERP systems and often are asked to audit validations performed internally. As a result of this experience we are familiar with strategies that eliminate compliance risk and minimize the effort required for initial validation and ongoing maintenance. If you are struggling with validation of a LIMS or ERP system, give us a call. We can offer checklists, sample plans and procedures, personnel, or specifications that can aid in simplifying your existing projects.
Software Development – we can assist with your regulated software development needs
We have highly experienced developers that are excellent at quality code development and resolving critical software defects. Our development practices are in compliance with IEC 62304:2006, the FDA consensus standard for Medical device software – Software lifecycle processes.
Software Code Review is one of our core competencies
As experienced software developers we are also expert in providing software code reviews. Our code reviews confirm adherence to industry best practices and include custom tools to evaluate code quality and reliability metrics. Our code review reports identify problem code and also provide recommendations for enhancing code quality to prevent future problems.
Manufacturing Process and Software Validation for Pharmaceutical Companies
We can offer significant expertise for the validation of manufacturing processes and software systems. Our expertise includes the preparation of validation procedures, specifications, protocols, execution of protocols, and preparation of validation reports. Our clients have realized significantly reduced validation costs and schedules by using our validation services.
Audit Services
We have conducted compliance and productivity audits for hundreds of medical device and pharmaceutical manufacturers. We offer experienced RABQSA certified auditors that focus on substantive observations that can adversely affect product quality or may be a significant nonconformance observation from a regulatory body.
Defect Management
Utilize CCS’ proven independent defect management process to ensure thorough tracking of defects and increased safety assurance through use of our risk based methods. |
