MDSAP, ISO and Quality System Audits

Quality management systems (QMS) continue to become harmonized across international borders.  With the ever-changing quality landscape, it is important to assess your QMS against various regulations and standards, particularly 21 CFR Part 820 and ISO 13485.

Our experienced auditors have been conducting audits that focus on the harmonized regulations including the Medical Device Single Audit Program (MDSAP).

• Over 300 quality system and process improvement audits
• Audits that target compliance with FDA regulations and ISO standards
• Practical audit recommendations that are based on best practices from industry leaders
• Audit recommendations that have resulted in significant cost savings
• Support for preparing responses to observations that minimize risk of future compliance actions

If you need any support for Quality System or ISO compliance audits, please contact one of our recognized experts.

Regulatory Support – Inspections

Experience includes:

• Participation in over 80 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.

The European Medical Device Regulation has changed the manner in which companies must approach entering the medical device markets of the European Union. These changes can greatly impact a company in the manner in which they implement the processes to develop, manufacture, and maintain their medical devices.

The requirements for a medical device Technical Documentation File to get an EU-MDR, CE Mark are complex.  Gaps should be assessed to assure that the EU-MDR Technical Documentation File is complete and supports a successful review.  These elements include but are not limited to:

• Classification of products and devices
• General Safety and Performance Requirements (GSPR)
• Clinical evaluation throughout the lifecycle of the device
• Inclusion of clinical evaluation to risk management activities
• Unique Device Identification (UDI) and labeling
• Periodic Safety Update Reports (PSURs)
• Post-Market Surveillance process (PMS)
• Trend reporting of adverse events in accordance with Article 88

CCS can help you better understand the EU-MDR regulations and simplify your procedures to help assure compliance, ultimately resulting in an improved quality management system.

Quality Management System Implementation (QSR, QMSR, ISO 13485)

Experience includes:

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.

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.

Design Control and Validation

Experience includes:

• 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.

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 as a result of our interaction with 100’s of medical device companies.

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 support for any of your quality assurance department needs please contact one of our CCS experts.

Training Support Services

Experience includes:

• 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.