Tanya Shalem LLC
Regulatory
Success and
Quality Excellence
Providing Practical Regulatory and Quality Solutions for MedTech and Life Science Companies
Regulatory
About Us
Navigating Complexity: Practical Solutions, Vision, and Integrity
Tanya Shalem LLC provides quality and regulatory consulting led by Tanya Shalem and a team of skilled
professionals. We partner with MedTech and Life Science companies to turn complex global requirements
into a clear path for growth. With a foundation in engineering and over 18 years of experience, we
provide hands-on execution for worldwide submissions, including FDA and CE Mark, alongside robust QMS
implementation per ISO 13485, FDA QMSR, MDSAP and EU MDR requirements.
We focus on the alignment between technical innovation and compliance by specializing in customized
solutions based on your organization’s specific needs, products, and size. Whether managing regulatory
and quality projects, gap assessments, remediations, or direct communication with Notified Bodies and
the FDA, we work as an integral part of your team. Partners choose us because we combine deep
technical mastery with a commitment to integrity and leadership, ensuring you not only secure market
access but also build a resilient culture of quality that lasts.
Our Services
How We Support Your Team
Global Regulatory Access
Regulatory strategy, FDA submissions, EU MDR technical
documentation, and worldwide product registrations.
Quality Management System Excellence
Implementation of robust QMS processes,
advanced design control, auditing, post-market compliance and adherence to state-of-the-art
standards and regulations.
Strategic Capability Building
Specialized Executive Leadership Coaching to
develop quality and regulatory leaders, equipping them with practical strategies to foster a
strong, enduring compliance culture and build high-performing teams.
Our services are tailored to the needs of growing and established medical device and life science organizations that value structured, compliant, and sustainable pathways to market.
Why Choose Us
A Trusted Partner in a Complex Regulatory Environment
Partners value our clear communication, ownership for execution, and steady support.
By blending a technical engineering foundation with a strategic business mindset, we turn high-stakes
global requirements into clear, actionable paths for growth. Whether we are securing regulatory
approvals for your latest innovation or building a robust QMS that scales with your success, we are
here to ensure your technology reaches the patients who need it, backed by a culture of integrity and
excellence.
Contact Us
If you have an upcoming audit, submission, or quality system initiative that requires a practical and technical approach, we are here to help you bridge the gap.