Ideal for SMEs, our membership scheme allows you to easily access the full scope of regulatory and quality expertise at the highest level, as and when you need it, and with complete cost control. Reduce overall risk and improve efficiency, quality and performance by having this in-depth skillset on hand to ensure a smooth certification process, successful audits and continually compliant systems.
Benefits for all members
All members can choose either a monthly or yearly subscription.
All members are free to arrange their hours as needed.
All members have access to our team of regulatory and quality experts and professional network.
All yearly subscriptions will have a dedicated quality manager.
40 or 100 hours per month
20 hours per month
10 hours per month
What we offer:
Clear, quick and agile solutions and strategies to secure CE certification.
Hands-on expertise and sounding board for your questions and ideas.
QMS set-up in line with ISO 13485 and MDR (EU) 2017/745 requirements.
Manage all quality and regulatory related topics, including production support and hygiene expertise.
Review and maintenance of your QMS, all technical documentation and SOPs in line with the related regulation and standards, ensuring continued compliance.
Finding, selecting and managing all interactions with your chosen Notified Body.
Post-market surveillance support to meet regulatory requirements.
Mentoring or full support for your regulatory or quality teams to manage compliance and strengthen performance.