Approach:Many companies request our services to evaluate their quality systems for not only compliance but also alignment with industry best practice. We have numerous sample procedure, checklists, and sample specifications that guide companies on a path to become best in class. We tailor your practices to focus on the key elements that will eliminate regulatory risk while reducing development times and maintaining a focus on product quality.
The regulatory system services we offer includes:
Quality Systems and Regulatory Support – Inspections
Experience includes:
- Conducted over 200quality system and process improvement audits
- Audits have targeted compliance with FDA regulations and ISO standards as well as process improvement.
- Practical audit recommendations are based on best practices from industry leaders.
- Audit recommendations have resulted in significant cost savings and reduced time to market as well as assured regulatory compliance.
- Participation in over 70 FDA inspections
- Minimizing 483 inspectional observationsthrough pre-inspection mock audits that focus on key elements of FDA “enhanced” QSIT inspection approach
- Conduct of pre-inspection training that focuses on how to guide inspectors to company best quality practices and identifies optimal strategies for presenting key quality subsystems (CAPA, MDR processes, process and design validation…)
If you need any support for Quality System or ISO compliance audits, contact one of the industries recognized experts in premarket submissions at info@certifiedcompliance.com
Regulatory Support – Inspections
Experience includes:
- Participation in over 70 FDA inspections
- Minimizing 483 inspectional observationsthrough pre-inspection mock audits that focus on key elements of FDA “enhanced” QSIT inspection approach
- Conduct of pre-inspection training that focuses on how to guide inspectors to company best quality practices and identifies optimal strategies for presenting key quality subsystems (CAPA, MDR processes, process and design validation…)
If you need help in preparing for an FDA inspection or an ISO audit 0contact one of our industry experts at info@certifiedcompliance.com
Regulatory Support Services – Submissions
- We have supported over 150 510(k)s and dozens of PMAs and BLAs
- We provide guidance on how to use “pre-submission” meetings to guide the reviewers on key device features and to reduce risk of questions that drive more detailed studies.
- We help in defining non-filing decisions for product changes reducing requirements for new submissions.
- We define long term strategies for submissions reducing submissions required and risk of review times delaying product launch.
- We package submissions in a format that summarizes key data and targets reviewer questions minimizing review delays.
On Site Training Support Services
Experience includes:
- Based upon practical experience learned 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 workshops that ensure that the lessons can be practically applied to your company.
If you need any support for onsite training contact one of the industries recognized experts in premarket submissions at info@certifiedcompliance.com
Our audits target compliance with FDA regulations and ISO standards as well as process improvement.- Our practical audit recommendations are based on best practices from industry leaders.
- Our audit recommendations have resulted in significant cost savings and reduced time to market as well as assured regulatory compliance.
- Our pre-inspection training focuses on how to guide inspectors to company best quality practices and identifies optimal strategies for presenting key quality subsystems.
- We provide support for preparing responses to observations to minimize risk of follow-on compliance actions.
If you need any support for Quality System or compliance audits, contact one of our experts at
The quality system services we offer includes:
Quality Management System Implementation
Experience includes:Definitionof quality system procedures based on the FDA Quality System Regulation and ISO 13485:2016 Medical devices - Quality management systems. These procedures:
- Are aligned and traced to applicable FDA regulations and ISO standards.
- Have proven to be effective through multiple successful FDA inspections and ISO audits.
We provide tailoring services for our generic procedures to adjust to the particular practices of each company. Use of our established procedures has proven to be much more cost effective and takes considerably less time than writing procedures from scratch.
Customer praise for use of our quality system procedures includes “Use of the CCS quality system procedures has allowed us to implement our quality system in a fraction of the time and cost that we would have spent in implementing our quality system through other consulting companies. Based on the training that is provided with these procedures by CCS we are also much more confident on how to defend our quality system for any future FDA or ISO audits. Use of the CCS quality system procedures has also freed our personnel to devote their time to their key areas of expertise.”
If you need support for implementing quality systems, contact one ofour experts in quality system implementation atinfo@certifiedcompliance.com
Design Control and Validation
Experience includes:
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- We simplify procedures to focus on key documents and using a risk based approach to focus on essential document content.
- We provide traceability checklists to show how technical specifications align to applicable standards/regulations (FDA, ISO, IEC…)
- We have extensive experience with the software requirements as defined by IEC 62304:2015 Amendment 1 Medical device software – Software lifecycle processes.
- We provide copies of our sample documents to facilitate preparation of your technical specifications.
- We use risk based methods to optimize the level of detail required for technical specifications.
If you need support for implementing design control requirements contact one of our experts at info@certifiedcompliance.com
Non-product software validation Support Services
- We help identify key applications that require validation based on assessment of regulatory requirements.
- We use Part 11 checklists to highlight compliance areas.
- We use a risk based procedures that simplify the number of documents and content required for satisfying validation requirements.
- We simplify decisions processes for determining re-validation requirements.
- We preparevalidation summary reports with traceability tables to show compliance to regulations, procedures and established requirements.
If you need support for non-product software validation contact one of our experts at info@certifiedcompliance.com
Quality Assurance Services
Experience includes:
We can provide highly qualified QA engineers that leverage the complete experience base of CCS. We can augment your QA group on a part time basis with costs that are cheaper than hiring full-time employees.
We have libraries of proven procedures and checklists that facilitate documentation of QA decisions. We conduct internal audits that include sharing of lessons learned from medical device industry leaders. We are very familiar with FDA expectations for QA processes due to our interaction with 100’s of companies.
Our services include:
- Preparation of quality system procedures
- Conduct of internal audits
- Serving as an independent reviewer in technical reviews
- Review and approval of defect classification and corrective actions
- Review and approval of complaints and MDR filing decisions
- Support for implementing and processing CAPAs
- Management of quality system and project metrics
If you need any support for your quality assurance department contact one of our experts at info@certifiedcompliance.com