Many companies request our services to evaluate their quality systems for not only compliance but also to align with industry best practices.
We have numerous sample procedures, checklists and specifications that help companies achieve best in class performance.
We customize your procedures to focus on the key elements to eliminate regulatory risk and reduce development and submission timelines.
The regulatory system services we offer include:
Quality System and Regulatory Support
- Over 200 quality system and process improvement audits
- Audits that target compliance with FDA regulations and ISO standards as well as process improvement
- Practical audit recommendations that are based on best practices from industry leaders
- Audit recommendations that have resulted in significant cost savings and reduced time to market as well as assured regulatory compliance
- Support for preparing responses to observations that minimize risk of follow-on compliance actions
If you need any support for Quality System or ISO compliance audits, please contact one of our recognized experts.
Regulatory Support – Inspections
- Participation in over 70 FDA inspections
- Minimizing 483 inspectional observations through pre-inspection mock audits that focus on key elements of the 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 please contact one of our industry experts.
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 reviewers on key device features and reduce risk of questions that may drive the need for 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.
Training Support Services
- We provide services based upon practical experience learned from our significant industry exposure.
- 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, Part 11 compliance, managing regulatory audits, premarket submissions, and many more quality and 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 individual company.
If you need any support for on-line or on-site training please contact one our industry training experts.
Recent changes in the European regulatory environment have led to changes in expectations for the implementation of a compliant Quality Management System (QMS). The Medical Device Regulation (MDR) which was implemented in May of 2017 drives changes to the previous Medical Device Directive (MDD). These changes can greatly impact a company on the manner in which they implement processes to develop, manufacture and maintain their medical devices.
Changes between MDD and MDR are significant and impact many portions of the QMS. Full implementation should be assessed in an internal audit to ensure that the appropriate changes are fully documented, implemented and defensible. Elements such as the ones mentioned below have been significantly impacted or added in MDR:
- Classification of products and devices
- Increased controls and responsibility for distributors and importers
- Periodic Safety Update Reports (PSURs)
- Trend reporting of adverse events in accordance with Article 88
- Technical Documentation
- General Safety and Performance Requirements (GSPR)
- Unique Device Identification (UDI) and labeling
- Increased focus on clinical evaluation throughout the lifecycle of the device
- Inclusion of clinical evaluation to risk management activities
- Increased focus on Post-Market Surveillance process (PMS)
CCS can help you better understand the intentions of the regulation and simplify your procedures to help ensure compliance, ultimately resulting in an improved quality management system, compliant with the regulations of MDR.
The quality system services we offer include:
Quality Management System Implementation
Definition of 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 numerous FDA inspections and ISO audits.
We provide tailoring services based on our established procedure templates to adjust to the particular practices of each individual company. Use of these procedures has proven to be much more cost effective and considerably less time than writing procedures from scratch.
An example of customer praise for use of our quality system procedures includes the following testimonial from one our customers.
“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 a practical, manageable and compliant quality management system, please contact one of our industry experts.
Design Control and Validation
- We simplify procedures to focus on key documents and use a risk based approach to focus on essential document content.
- We provide traceability checklists to demonstrate how technical specifications align to applicable standards and regulations (FDA, ISO, IEC…)
- We have extensive experience with 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, please contact one of our CCS experts.
Non-Product Software Validation Support Services
- We help identify key applications that require validation based on assessment of regulatory requirements.
- We use 21 CFR Part 11 checklists to highlight compliance areas.
- We use risk based procedures that simplify the number of documents and content required for satisfying validation requirements.
- We simplify decision processes for determining re-validation requirements.
- We prepare validation summary reports that include traceability tables to show compliance to regulations, procedures and established requirements.
If you need support for non-product software validation, please contact one of our CCS experts.
CCS has extensive experience in testing a wide variety of medical device products resulting in understanding of common errors experienced by many companies. We combine ad hoc testing with structure testing scenarios to isolate the cause of the defect(s). We also know how to induce maximum loading of processors, memory, and communications to identify hard to reproduce defects. We have been consistently successful in re-creating defects where others have failed and classified these defects as “non-reproducible”.
We know that many defects are discovered when attempting to follow complex user workflows. Understanding the users and work environment helps us to focus on the areas of use that are most complex and most likely to have the potential for users to encounter defects. In some cases, the understanding of these more complicated areas of device use can help to better design the user interface.
Quality Assurance Services
- 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 as a result of our interaction with 100’s of medical device companies.
- 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 support for any of your quality assurance department needs please contact one of our CCS experts.