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Services |
My goal is to find a solution that benefits your company current and future situation. Below are examples of services I offer. In a first step, we will sit together to understand your needs and create a tailored proposal. Feel free to scroll through below examples or contact me immediately to start tailoring that solution.
Whichever the project content and size, I always aim to provide a solution that fits your company culture, size, strategy and future.
QMS Implementation
Are you launching a new medical device? Maybe increasing the risk and potentially classification? Do you need to implement or strengthen your Quality Management System for compliancy to EU MDR, FDA 21CFR820 or ISO 13485:2016? Is your QMS compliant but you struggle to make it effective?
Together we can define a project to support your company to achieve this as soon as possible. The sooner your QMS is up to standard, the less corrections you will have to apply to current on-going processes such as Research & Development or the setup of production, and the sooner the QMS can reduce cost.
Together we can define a project to support your company to achieve this as soon as possible. The sooner your QMS is up to standard, the less corrections you will have to apply to current on-going processes such as Research & Development or the setup of production, and the sooner the QMS can reduce cost.
Training/Education/Coaching
Because of my passion for Quality Assurance, I love training, educating and coaching anyone involved in (medical) Quality. By spreading knowledge on QA in your organisation, you not only ensure everyone speaks the same language but you will also detect and prevent risks earlier.
Training programs can be adapted to your needs and can vary from a classroom style teaching class, to a one or multi-day workshop or even long term coaching of an employee to become your QA/RA manager.
Training programs can be adapted to your needs and can vary from a classroom style teaching class, to a one or multi-day workshop or even long term coaching of an employee to become your QA/RA manager.
Quality Assurance Management
Quality Assurance and associated risk control depends on the proficiency of your QMS. A big factor is however the personnel involved in the execution, monitoring and control of that QMS to ensure fast action when a gap or risk is identified.
For your company size, growth trajectory and current focus, a dedicated full time Quality Assurance/Regulatory Affairs manager might not be right solution (yet). Or maybe you need to temporarily replace a QA staff member. Whatever your need, Whether it is 1 day/week operational Quality Management or full time replacement for a few months, I might be able to help you out.
Contact me and let's see if we can find a solution that suits your needs.
For your company size, growth trajectory and current focus, a dedicated full time Quality Assurance/Regulatory Affairs manager might not be right solution (yet). Or maybe you need to temporarily replace a QA staff member. Whatever your need, Whether it is 1 day/week operational Quality Management or full time replacement for a few months, I might be able to help you out.
Contact me and let's see if we can find a solution that suits your needs.
Audit
All organisations evolve and so should their QMS. Audits are necessary to ensure that evolution is going in the right direction and at the right pace. An audit can identify compliance gaps, ineffective costly processes or simply provide reassurance your company is ready for that certification audit or inspection expected next month.
Besides auditing internal processes, external processes from suppliers might require auditing too. Depending on your time, resources and confidentiality agreements, it might not be feasible to have those performed by your own staff.
I can audit those processes for your company. Contact me and we can discuss a tailored audit project with the focus you need.
Besides auditing internal processes, external processes from suppliers might require auditing too. Depending on your time, resources and confidentiality agreements, it might not be feasible to have those performed by your own staff.
I can audit those processes for your company. Contact me and we can discuss a tailored audit project with the focus you need.
CE Technical File / 510(k) Submission
No medical device can be put on the market in Europe or in the US without registration and a technical assessment, depending on the risk classification. If you need advice, help or support to create a CE technical file or 510(k) submission, I'm sure I can be of benefit to your firm. I'm experienced in these processes and my engineering background, both in hardware and software, helps me in understanding your device and easily co-operate with your R&D team.
Notified Body / FDA inspection
Is your company facing an inspection or external audit? I have experience with external audits and FDA inspections.
Although external audits and FDA inspections can be considered an opportunity to learn and improve, they can quickly turn into expensive nightmares if not addressed in the right way. To prevent this, preparation and a good plan is of paramount importance.
I have experience in external audits and inspections from customers, notified bodies and even a couple of FDA inspections. We can define a project to, for instance, perform a focused audit of the QMS, create a plan to close gaps were possible in the remaining available time, train your team in the audit/inspection scenario and/or support you during the audit as well as during the closing of any potential finding.
Although external audits and FDA inspections can be considered an opportunity to learn and improve, they can quickly turn into expensive nightmares if not addressed in the right way. To prevent this, preparation and a good plan is of paramount importance.
I have experience in external audits and inspections from customers, notified bodies and even a couple of FDA inspections. We can define a project to, for instance, perform a focused audit of the QMS, create a plan to close gaps were possible in the remaining available time, train your team in the audit/inspection scenario and/or support you during the audit as well as during the closing of any potential finding.
Project management
Sometimes tackling your next goal in Quality Assurance is a project on its own. Whether it is to digitize your paper based document management system, to address a serious non-conformity or expanding to a new market with its own regulations, the health of a project is always affected by the quality of the management of that project.
For such projects, it is assuring to know your project manager has knowledge of quality regulations, has been through QMS changes before and has the necessary people management skills.
Contact me if you have such a project and could use additional help.
For such projects, it is assuring to know your project manager has knowledge of quality regulations, has been through QMS changes before and has the necessary people management skills.
Contact me if you have such a project and could use additional help.
