What separates Med Dev QMS from other quality system template providers?
Med Dev QMS Procedures were originally developed by a medical device startup firm for internal use only. The system and organization was so successful that other local small businesses and startups in the area began implementing and optimizing the systems within their companies. We quickly realized that these simple, straight-forward, efficient procedures truly minimized the non-value adding paperwork activities and allowed these small medical device companies to focus resources on their primary goal, developing medical devices. Med Dev QMS Templates were born with the focus of the needs of startup and small medical device companies. This is in direct contrast with some of the other template providers, particularly the low cost options. These providers tend to just reword the actual standards while providing excessive requirements and forms that weigh down the system, eat up resources, and slow down development.
Who needs quality system templates and what should I look for in a package?
All providers of medical devices sold in the US are required by the US FDA to implement a quality management system that is compliant with US CFR 21 Part 820, better known as FDA QSR. This applies to Class I, II, and III medical devices whether your are a manufacturer, specification developer, importer, etc. Most other countries require compliance to ISO 13485 :2016 and many organizations are requiring their suppliers to obtain ISO 13485 certification. Given the FDA QSR and ISO 13485 share most of the same requirements, we strongly recommend systems that are compliant with both. The 2016 version of ISO 13485 is crucial as all other versions are obsolete as of 2019. Risk Management (ISO 14971) is also required by the medical device regulations. Finally, there is a huge difference between quality system templates focused toward the pharma industry versus the medical device industry. The template package you decide upon should be focused on the type of products that you are developing and looking to bring to market.
When should a startup medical device company commit to implementing quality systems?
Your company should begin to implement quality systems as soon as you have a concept prototype. The first system to implement is the Design Control System. This is because Design Controls are extremely beneficial to developing effective medical devices and will provide the foundation to create the documentation necessary to achieve FDA market approval and create a Technical File. A 510(k) submission will take a minimum of 90 days to gain approval and during this time, you can work to implement the remaining applicable systems. For Class II and III Medical Devices, the FDA will almost certainly audit your quality management system within 30 days of listing your device for distribution. For EU distribution, your quality system will have to successfully complete an ISO 13485 certification audit from a notified body in addition to auditing the Technical file. The Med Dev QMS Templates will expedite the implementation process and help you get to market faster.
Some forums and other website suggest templates result in poor audit results.
First we need to clear up a misconception, it is not possible to just implement a set of templates and hope for the best. There is a significant amount of effort necessary to implement a quality system specific to your organization. Auditors are looking for records and evidence that quality systems are not only implemented, but utilized by the organization. Med Dev QMS Templates provide a solid foundation to begin this process. The other thing to keep in mind is the motivations of the people posting these comments. Consultants hate templates because they want to create your quality systems for $150+ per hour and bill you at least 20 hours. The Med Dev QMS Templates will not eliminate the need to implement and utilize the quality systems. They will reduce risk, simplify the optimization process, and ensure your quality management system meets the requirements of FDA QSR and ISO 13485:2016.
Software systems versus template systems.
Beside the additional cost and subscription fees associated with software QMS systems, it is important to develop your quality systems to fit the needs and requirements of your organization. This is a challenging task by itself. Adding the complexity of integrating customized software into the equation often results in poor systems that are inefficient and end up weighing down the organization. We always recommend implementing and optimizing a quality system before trying to automate with software. The benefits of software do not generally justify the expense and resources necessary to implement until the organization has achieved success and expand towards 100+ employees. Template systems are a far better choice for startup and small business that are just beginning the development and ramp-up phase.
Why are there different numbers of procedures with different companies?
Some companies believe the more quality procedures provided, the more value the template package offers. While this makes sense with some products, this is the exact opposite for medical device quality systems. The more procedures, the more requirements, the more man-hours required to manage, the more opportunities for issues during audits. Once requirements are documented in your system, you are obligated to comply with them. The efficient procedure templates provided by Med Dev QMS reduce the focus on maintaining the quality systems and free up resources for developing great products.
How do I justify the cost of the templates?
This one is easy, the Med Dev QMS template package allows your organization to begin the quality system optimization process on day one. This will save hundreds of man-hours alone. Simply multiply the number of hours to just create these documents by the hourly rate of an experienced medical device quality professional (consultants will run $150+ per hour) and you will quickly see the inherent value. Save this time and money to spend towards designing and producing great products. Additionally, Med Dev QMS Templates are battle tested. Do not waste precious resources reinventing the wheel. We have spend years optimizing this system, let us help you focus on the things that add value to your organization.
Med Dev QMS Procedures were originally developed by a medical device startup firm for internal use only. The system and organization was so successful that other local small businesses and startups in the area began implementing and optimizing the systems within their companies. We quickly realized that these simple, straight-forward, efficient procedures truly minimized the non-value adding paperwork activities and allowed these small medical device companies to focus resources on their primary goal, developing medical devices. Med Dev QMS Templates were born with the focus of the needs of startup and small medical device companies. This is in direct contrast with some of the other template providers, particularly the low cost options. These providers tend to just reword the actual standards while providing excessive requirements and forms that weigh down the system, eat up resources, and slow down development.
Who needs quality system templates and what should I look for in a package?
All providers of medical devices sold in the US are required by the US FDA to implement a quality management system that is compliant with US CFR 21 Part 820, better known as FDA QSR. This applies to Class I, II, and III medical devices whether your are a manufacturer, specification developer, importer, etc. Most other countries require compliance to ISO 13485 :2016 and many organizations are requiring their suppliers to obtain ISO 13485 certification. Given the FDA QSR and ISO 13485 share most of the same requirements, we strongly recommend systems that are compliant with both. The 2016 version of ISO 13485 is crucial as all other versions are obsolete as of 2019. Risk Management (ISO 14971) is also required by the medical device regulations. Finally, there is a huge difference between quality system templates focused toward the pharma industry versus the medical device industry. The template package you decide upon should be focused on the type of products that you are developing and looking to bring to market.
When should a startup medical device company commit to implementing quality systems?
Your company should begin to implement quality systems as soon as you have a concept prototype. The first system to implement is the Design Control System. This is because Design Controls are extremely beneficial to developing effective medical devices and will provide the foundation to create the documentation necessary to achieve FDA market approval and create a Technical File. A 510(k) submission will take a minimum of 90 days to gain approval and during this time, you can work to implement the remaining applicable systems. For Class II and III Medical Devices, the FDA will almost certainly audit your quality management system within 30 days of listing your device for distribution. For EU distribution, your quality system will have to successfully complete an ISO 13485 certification audit from a notified body in addition to auditing the Technical file. The Med Dev QMS Templates will expedite the implementation process and help you get to market faster.
Some forums and other website suggest templates result in poor audit results.
First we need to clear up a misconception, it is not possible to just implement a set of templates and hope for the best. There is a significant amount of effort necessary to implement a quality system specific to your organization. Auditors are looking for records and evidence that quality systems are not only implemented, but utilized by the organization. Med Dev QMS Templates provide a solid foundation to begin this process. The other thing to keep in mind is the motivations of the people posting these comments. Consultants hate templates because they want to create your quality systems for $150+ per hour and bill you at least 20 hours. The Med Dev QMS Templates will not eliminate the need to implement and utilize the quality systems. They will reduce risk, simplify the optimization process, and ensure your quality management system meets the requirements of FDA QSR and ISO 13485:2016.
Software systems versus template systems.
Beside the additional cost and subscription fees associated with software QMS systems, it is important to develop your quality systems to fit the needs and requirements of your organization. This is a challenging task by itself. Adding the complexity of integrating customized software into the equation often results in poor systems that are inefficient and end up weighing down the organization. We always recommend implementing and optimizing a quality system before trying to automate with software. The benefits of software do not generally justify the expense and resources necessary to implement until the organization has achieved success and expand towards 100+ employees. Template systems are a far better choice for startup and small business that are just beginning the development and ramp-up phase.
Why are there different numbers of procedures with different companies?
Some companies believe the more quality procedures provided, the more value the template package offers. While this makes sense with some products, this is the exact opposite for medical device quality systems. The more procedures, the more requirements, the more man-hours required to manage, the more opportunities for issues during audits. Once requirements are documented in your system, you are obligated to comply with them. The efficient procedure templates provided by Med Dev QMS reduce the focus on maintaining the quality systems and free up resources for developing great products.
How do I justify the cost of the templates?
This one is easy, the Med Dev QMS template package allows your organization to begin the quality system optimization process on day one. This will save hundreds of man-hours alone. Simply multiply the number of hours to just create these documents by the hourly rate of an experienced medical device quality professional (consultants will run $150+ per hour) and you will quickly see the inherent value. Save this time and money to spend towards designing and producing great products. Additionally, Med Dev QMS Templates are battle tested. Do not waste precious resources reinventing the wheel. We have spend years optimizing this system, let us help you focus on the things that add value to your organization.