Regulatory Affairs
Our practical approach helps you bring your medical devices to market faster.
Know what's "Good Enough''
As a medical device (MD) or in vitro diagnostic (IVD) manufacturer, you face increasing regulatory pressure. Stricter requirements under the MDR and IVDR create significant additional regulatory burdens, especially when adapting legacy devices to the new frameworks.
Meeting these requirements demands more time, resources, and expertise from your internal teams.
The system is workable, but the challenge lies in the burden. Stricter regulatory requirements demand more documentation, evidence, and internal coordination. Meeting these new regulatory requirements poses challenges for legacy devices. Consequently, new developments or innovations are often postponed.
The key issues are knowing what is “good enough”, ensuring your documentation meets expectations from day one, and avoiding unnecessary iterations or rework during the review process.
At Qserve, we have decades of experience in Regulatory Affairs. We work with passion on regulatory, quality, and clinical challenges, sharing the same passion for medical technology, striving for high-quality standards, and always putting our customers first.
Satisfied Clients
Our regulatory affairs cover multiple disciplines. Discover all of them:
Regulatory Strategy Support
We provide strategic guidance to help you develop a roadmap for regulatory compliance and market access tailored to your specific product and target markets.
Dossier Submission Support
We support or write technical documentation and prepare for US FDA submissions or Notified body conformity assessments.
Interim Support
Whether you need temporary replacement of a QA/RA manager, regulatory expertise, project management, or technical support, our interim services provide the flexibility and expertise you need to succeed.
Audits & Assessments
We conduct in-depth audits and gap assessments to ensure compliance with global medical device regulations and standards, including MDR, IVDR, MDSAP, QMSR and ISO 13485.
Global Market Access
Looking to register your products worldwide? Qserve has the expertise and can manage the entire registration process on your behalf.
Regulatory Intelligence
Staying on top of changing regulations in the countries where you market your products is becoming increasingly complex. Qserve Insight is an innovative tool that provides targeted regulatory updates for your selected countries, including clear summaries and impact assessments to help you manage compliance efficiently.
Training
Advance your expertise with Qserve Learn. Our dedicated training for MedTech and IVD professionals is available online, remotely, or in the classroom. Anytime, anywhere.
Mergers & Acquisitions
We understand the high stakes in merger and acquisition processes, and address potential regulatory risks related to products and markets.
Use regulatory expertise to ensure compliance and avoid costly delays in the registration process. Fast track your market access.
Qserve takes a practical approach. We combine deep regulatory knowledge with hands-on industry and Notified Body experience to deliver tailored, efficient solutions aligned with real-world business needs. We strive for faster compliance and smoother market entry. First time right.
Use regulatory expertise to ensure compliance and avoid costly delays in the registration process. Fast track your market access.
Qserve takes a practical approach. We combine deep regulatory knowledge with hands-on industry and Notified Body experience to deliver tailored, efficient solutions aligned with real-world business needs. We strive for faster compliance and smoother market entry. First time right.
