We can help you
Within your company, you have some repetitive tasks that are done and you are willing to get some support to perform them.
Or you receive regular observations during audits because you miss some deadlines for your Management Review, supplier audits…
Then contact Easy Medical Device to help you with the BOSS program (BackOffice ServiceS). Check our offer below and contact us for more details.
What is the BackOffice ServiceS?
Easy Medical Device is a consulting firm specializing in Quality and Regulatory Affairs for Medical Devices. We have worked with many customers and identified that they have some recurring needs.
We then decided to create a Backoffice offer for them to manage their yearly budget. So no more surprises and the processes that you need us to take care of will be done on time.
How does this work?
Type of activities
We wanted to provide you with some examples of activities that we can take charge but this can be increased if there are more needs
We can provide you with internal audit services where an auditor can do that on-site or virtually.
The auditors will be qualified for multiple years of experience to the standards they are auditing.
Before the delivery of the report, an internal process will verify its content and evaluate if this is compliant with the requirements of ISO 19011.
Every year your company should perform a Postmarketing Surveillance. We can do that for you.
After we agree on the PMS Plan at the start of the mission, we will then agree on a delivery time for the report.
We will use internal data that you will provide us and external data that we’ll gather on the different databases to then provide you with the PMS report or PSUR.
Regulatory intelligence is an important activity that a lot of companies are not doing properly. We will do that every month for you with a report that will be issued identifying all the standard updates and all the legislation changes that may impact your product or company.
This report will include a summary of the changes so you can evaluate if this needs any actions from your side.
This will be a personalized report specific to you.
Per your agenda, we will prepare all the documentation needed for your Management Review.
Planning, agenda, presentation, collection of actions, report, attendance list… We will execute your procedure and support your team to deliver all the necessary information.
You can define regular training that should be done to your employees and we can deliver that per your requirements at a regular frequency
If your company has heavy supplier audit planning and you need support to perform them, then you can count on our team.
We will select consultants who will execute these audits for you and provide you with a report that will be compliant with your procedures and the legislation you are following.
No more excuses for missing a supplier audit.
As said these are just a sample of what we do actually for some companies. We have also done activities like recording of complaints for a company and management of the vigilance reporting.
So if you have an idea, let us know.
Performance and stability of your company
This process will help your company stay focused. You will have no more excuses to provide to a Notified Body or an external auditor for missing a deadline. Our team will keep track of your regular activities and then support your compliance process.
Contact us for the BOSS program
If you are curious about this offer then contact us by clicking on the button below. Fill in some information in the email and then send it to us.
We will contact you after receiving it. And we will then take care of everything.
We hope you’ll be integrating the BOSS Program
For more details, you will find a Back Office ServiceS Program Presentation in PDF format below.