Impactful regulatory and clinical affairs workflow
for MedTech without the micromanagement
Gain MedTech clinical regulatory expertise with our team
as your partners. Fast-track your innovation from device
concept to gaining clearance in the UK and EU market.
Innovate and create
impactful and market dominating
devices
Develop successful technologies
for healthcare that payers fund and
regulators approve
Effectively manage
regulatory barriers and outpace
competitors to expand your
market share
Frustrated with agencies,
software suppliers and
consultants that don’t
understand your medical
device needs?
Your service providers should deliver solutions and industry expertise to enhance your product planning and help you stand out in a crowded market. Moreover, they should lighten your workload, enabling you to dedicate more time to other growth initiatives.
Unfortunately, this is often not the case. Instead, you find yourself dealing with non-conformances, redoing work, allocating more budget/resources and struggling to build rapport with auditors while waiting for market clearance. It shouldn’t be this way.
Are you tired of:
Wasting money on software or recruited staff who don’t have the correct experience to create compliant regulatory documents for your device?
Allocating more spend to project manage outsourced staff or provide training to work around misaligned software?
Not getting solutions for the quickest route to market and explaining the essentials of IFUs and clinical data to non-specialists?
Wasting time fixing regulatory documents due to non-conformances?
Instead, get consistent and compliant clinical and regulatory workflows, without the need to supervise…
The Clinical Regulatory experts - It’s who we are
Currently, MedTech is demanding far greater clinical and technical expertise for regulatory clearance than a decade ago. Consequently, the industry is in a talent war for those with EU MDR proven CE clearance expertise. Therefore, that’s why we’ve assembled a team with a proven track record in meeting new regulatory standards.
Accuracy and track record matters
CLIN-r+ has a 100% success rate in achieving EU MDR CE. Indeed it is crucial that your consulting partner not only understands the details that impact patient lives, but truly cares about them.
Hence, allowing you to focus on developing your technology, product portfolios, and growing your revenue
Trusted Expertise for Your Needs
Get the regulatory experts needed to rapidly scale and extend your team’s expertise. Our team of MD regulatory STEM professionals (toxicologists, doctors, medical writers, researchers, biostatisticians, health economists, etc.) have necessary credentials to meet regulation and assure acceptance of applications..
Allowing you to be the
MedTech Innovator of choice
and build your brand
Technology is progressing quickly bringing exciting solutions to the healthcare market. It’s never been faster paced or competitive. Simultaneously, the need for strict regulations to ensure device safety and performance is at an all-time high and it’s not going to get easier.
That’s why CLIN-r+ offers an effective regulatory workflow, enabling you to demonstrate expertise to regulators and consistently meet market access milestones, reinforcing investor confidence in your company. With CLIN-r+, your regulatory team can focus on daily operations, confident that documentation is compliant and new innovations have scalable clinical regulatory support.
- Access to accredited professionals to scale your team
- Partnership with a consultancy with a 100% track record
- Regulatory strategy cross mapping for international expansion and efficiency of investment of validations
- Clinical data strategic planning and RIO against market needs
- Clear roadmap to market for investors and executive board
- Project idealisation and management support as part of your package
Start ensuring that your regulatory clearance is predictable and impactful to dominate your market
01.
Book a 30 minute introduction call with us
02.
Understand how we can help you develop a strategy or execute yours
03.
Extend your team’s capabilities with our regulatory experts.
01.
Book a 30 minute introduction call with us
02.
Understand how we can help you develop a strategy or execute yours
03.
Extend your team’s capabilities with our regulatory experts.
