Empowering Your Medical Device Business with Professional Consulting
Quality Compliance Excellence
Tulip-Talent
Tulip-Talent: Your Trusted Consulting Partner
Tulip-Talent is a global medical device consulting, Quality Management Systems auditing and training firm specializing in ISO 13485:2016 regulatory compliance for medical devices, IVDs and combination products. We help manufacturers/distributors/importers understand and comply with EU and MDSAP international regulatory requirements, ensuring their products meet the highest standards of safety and efficacy.
RA/QA Consulting Services
Internal Audit
Whether it's ISO 9001, ISO 13485 or ISO 17025. Tulip has got you covered.
Outsource your internal audit program today. Make it seamless and let us do all the work.
Regulatory Affairs and Compliance
Our global team is comprised of engineers and scientists who understand how medical devices, IVDs, and combination products work, how performance is measured, and what type of documentation and evidence is required. With former regulators and notified bodies on staff, we have unique insights into how regulatory bodies and reviewers are likely to respond.
Design & Manufacturing Quality Engineering
From new product development to manufacturing site transfer, Tulip has you covered.
Quality System Development & Auditing
Tulip uses a customized and business-balanced approach to develop quality systems that align with your organizational goals, from a detailed gap analysis to an implementation of a new regulation across an entire quality system. Furthermore, our dedicated global audit team has you covered, from internal and supplier audits to mock notified body and FDA inspections.
Post-Market Surveillance & Clinical / Performance Evaluation
In order to comply with EU MDR, you must have a PMCF plan in place and have it ready for review with your technical documentation. RQM+ has created MDR-compliant PMCF plans for a wide range of device types and clinical specialties tailored to ensure a business-balanced approach while demonstrating the clinical benefit of your product.
When developing a PMCF plan, it is important to know what data you need to be capturing. Our clinical evidence matrix highlights gaps and weaknesses so we can help tailor a strategy for telling the complete clinical story.
Project Management
We can help you manage complex projects from start to finish, adhering to regulatory compliance and ensuring that they are delivered on time.
Training and Support
We offer comprehensive training and support services to help you get the most out of your QMS, and to ensure that your team is equipped with the skills they need to succeed.
Online Payment
Easily pay for services online with Tulip-Talent's secure and user-friendly payment platform.