Client
Start up Medical Device company in need of a compliance audit
Business Challenge
Scaling the client’s Regulatory Affairs and Quality Assurance team due to accelerating growth.
About QMS for Medical Devices
The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).
Client Challenge
A start up medical device company needed assistance scaling their Regulatory Affairs and Quality Assurance team due to unforeseen growth. Their FDA approved Class II device received exceptional press at multiple industry events and trade shows. Additionally, the team was required to scale quickly as unit sales escalated rapidly within less than a year after product launch.
RCA’s Approach
Regulatory Compliance Associates (RCA) medical device consultants strategized about both short and long term needs of the client. Several members of the client senior leadership team work remotely outside their corporate office. Designing a program around flexibility was important to this group.
Multiple subject matter experts were assigned to provide support for each department of the remote employees. In addition, the client was engaging with a new contract manufacturer (CMO) with greater manufacturing capacity than an existing vendor. A longer-term strategy was put in place to meet growing demand and validate the new CMO’s compliance via an ISO compliance audit.
Manufacturing Support
RCA partnered with the Operations team to perform a supplier audit of the CMO during the initial scope of work. This included RCA medical device consultants reviewing the design control plan, how risk management was incorporated into outputs, a gap analysis of working instructions, and other facets of ISO 13485 compliance support.
Quality Management System
Simultaneously, a second RCA medical device consultant was engaged to partner with the Quality Assurance department. A quality management system (QMS) internal audit was conducted to validate existing standard operating procedures and design history file (DHF) documentation.
Compliance Audit
RCA’s medical device consulting services included performing a compliance audit against both the 21 CFR 820 regulation the product was originally approved for & ISO 13485 global standard. Based on the records in the common technical document, several gaps were identified for remediation. These compliance audit gaps included updates to control plans, process flows, and supplier quality agreements.
Regulatory Documentation
Additionally, establishing a more robust Device Master Record (DMR) to centralize all documents was important to the client. A product family structure was developed in the QMS to help clean legacy data & organize technical documents more efficiently.
Finally, RCA’s MDR consultants also worked with the client team to analyze the existing documentation. A project checklist was created to help with submitting any new files needed for regulatory approval in the EU based on ISO 13485.
Summary
RCA’s medical device consulting experts addressed the gaps that, once remediated, led to the contract manufacturing line being validated as cGMP compliant. The client is now working with an additional RCA compliance consultant to initiate several corrective and preventive action (CAPA) programs to address the updated internal process. Additionally, the CAPA strategy will help provide the client objective examples that corrective action prevents deviations in standard operating procedure.
Finally, the RCA medical device consulting team conducted an operations team training meeting to review regulatory compliance, cGMP manufacturing and compliance audit updates.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
Client
Start up Medical Device company in need of a compliance audit
Business Challenge
Scaling the client’s Regulatory Affairs and Quality Assurance team due to accelerating growth.
About QMS for Medical Devices
The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).
Client Challenge
A start up medical device company needed assistance scaling their Regulatory Affairs and Quality Assurance team due to unforeseen growth. Their FDA approved Class II device received exceptional press at multiple industry events and trade shows. Additionally, the team was required to scale quickly as unit sales escalated rapidly within less than a year after product launch.
RCA’s Approach
Regulatory Compliance Associates (RCA) medical device consultants strategized about both short and long term needs of the client. Several members of the client senior leadership team work remotely outside their corporate office. Designing a program around flexibility was important to this group.
Multiple subject matter experts were assigned to provide support for each department of the remote employees. In addition, the client was engaging with a new contract manufacturer (CMO) with greater manufacturing capacity than an existing vendor. A longer-term strategy was put in place to meet growing demand and validate the new CMO’s compliance via an ISO compliance audit.
Manufacturing Support
RCA partnered with the Operations team to perform a supplier audit of the CMO during the initial scope of work. This included RCA medical device consultants reviewing the design control plan, how risk management was incorporated into outputs, a gap analysis of working instructions, and other facets of ISO 13485 compliance support.
Quality Management System
Simultaneously, a second RCA medical device consultant was engaged to partner with the Quality Assurance department. A quality management system (QMS) internal audit was conducted to validate existing standard operating procedures and design history file (DHF) documentation.
Compliance Audit
RCA’s medical device consulting services included performing a compliance audit against both the 21 CFR 820 regulation the product was originally approved for & ISO 13485 global standard. Based on the records in the common technical document, several gaps were identified for remediation. These compliance audit gaps included updates to control plans, process flows, and supplier quality agreements.
Regulatory Documentation
Additionally, establishing a more robust Device Master Record (DMR) to centralize all documents was important to the client. A product family structure was developed in the QMS to help clean legacy data & organize technical documents more efficiently.
Finally, RCA’s MDR consultants also worked with the client team to analyze the existing documentation. A project checklist was created to help with submitting any new files needed for regulatory approval in the EU based on ISO 13485.
Summary
RCA’s medical device consulting experts addressed the gaps that, once remediated, led to the contract manufacturing line being validated as cGMP compliant. The client is now working with an additional RCA compliance consultant to initiate several corrective and preventive action (CAPA) programs to address the updated internal process. Additionally, the CAPA strategy will help provide the client objective examples that corrective action prevents deviations in standard operating procedure.
Finally, the RCA medical device consulting team conducted an operations team training meeting to review regulatory compliance, cGMP manufacturing and compliance audit updates.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
