Your Compliance Companion
Is your organisation compliant?
Is a change coming and you need to prepare?
Or do you just need an extra pair of hands to ensure compliance?
... Let's talk.
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Quality Management Systems
If you are looking to implement a Quality Management system or require scope extension we can help. We have experience in ISO9001, ISO13485 including MDSAP and can tailor your Quality Management System for your specific needs.
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Medical Device and Technical Files
Whether you’re completing Design History Files, Product Summary Files or Medical Device Technical Files for the first time, or are struggling with file remediation or maintenance we are here to help. We have experience with working directly with various Notified Bodies
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Training
Make sure your team has the skills needed to understand and comply with the most recent changes to regulations with one of our training courses. We understand how time consuming this can be. We can offer flexible solutions with an aim to minimise disruption.
Not sure where to start?
Reach out to a member of our team today so we can help you find the best
options to suit your needs.
Ways you can work with us…
Monthly Support
If you need regular support for your organisation, then a monthly retainer could be the solution for you. It would give you the peace of mind that we are available for you for as long as you need us to answer your questions, conduct reviews or complete project tasks.
If you are unsure of how much support you need, are looking for an expert that you can call on when required or do not want to commit to a retainer package, then you may prefer to purchase a fixed block of hours. These can be used as and when you need them. At the end of each month, we will send you a confirmation timesheet to let you know the hours worked and what credit you have still available.
Project Work
If you need support on a specific project, such as; Supplier Audits, developing and delivering bespoke training, QMS Remediation or Technical File remediation, we can help. This includes on and off site support.
Contact Us
Where does your business need more support? We offer a broad range of services and packages that can be customised for your needs. For a free, no-obligation consultation session reach out to us at reach@colloccoconsultancy.com. We would be delighted to hear from you.