Impactful regulatory and clinical affairs workflow

for MedTech without the micromanagement

Gain a MedTech clinical regulatory expert team
as partners that can help you from device
concept to messaging to marketing execution.

Innovate and create
impactful, market-leading
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.

Regulatory clinical affairs workflow

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

MedTech now demands far greater clinical and technical expertise for regulatory clearance than a decade ago. The industry is in a talent war for those with EU MDR proven CE clearance expertise. That’s why we’ve assembled a team with a proven track record in meeting new regulatory standards.

Impactful regulatory clinical affairs workflow.

 

Accuracy and track record matters

CLIN-r+ has a 100% success rate in achieving EU MDR CE. It’s crucial that your marketing partner not only understands the details that impact patient lives, but truly cares about them.

Expertise you can trust

Our team consists of regulatory experts from a STEM background (toxicologists, medical writers, medical researchers, biostatisticians, health economists, etc.). They have necessary credentials for regulators to accept your applications. By integrating these experts into your projects, we extend your team’s capabilities, ensuring your regulatory strategy and documentation are expertly handled. Allowing you to focus on developing your technology, product portfolios, and growing your revenue.

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.

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.