Contract Regulatory Staffing Solutions (End-to-End Support)
Looking for Staffing Solutions?
Finding qualified regulatory staffing talent on time is a major challenge in the Healthcare and Life Sciences sector. This becomes even more critical during process upgrades or when adapting to new compliance requirements.
At Morulaa HealthTech, we offer Regulatory Compliance Services globally, helping companies with temporary or project-specific needs while supporting foreign manufacturers with medical device registration and regulatory compliance through a strong recruitment team and a global network of skilled professionals. Our experienced professionals and consultants can quickly step in to support your team, solve problems, and speed up compliance work, especially for EU IVDR (In vitro diagnostics).
Core Market? Medical Device Registration & Regulatory Compliance Services
Timeline Gap? EU MDR and EU IVDR Submissions
Entering New Regions? Medical Device Registration Support
Special Projects? In Vitro Diagnostics and EU MDR Projects
Paperwork Overload? Regulatory Compliance Services
Need More Resources? Medical Device Staffing
Ideal for Startups Seeking Regulatory Compliance Services
Teams Struggling? EU IVDR Medical Device Projects
Expanding Globally? Medical Device Registration and EU MDR Compliance
Quick Submissions? EU MDR and EU IVDR Devices
The Benefits We Offer To Your Organization For Medical Device Registration
Hiring regulatory contractors or consultants enables you to manage urgent workloads or project demands efficiently, allowing your team to stay focused on core strategic goals.
Improve workforce retention with Medical Device Registration support.
Save your time and money with Medical Device Registration.
Regulatory Compliance Services to ensure contract workforce compliance.
Achieve optimal results through expert Medical Device Staffing
Our Team: Expert Regulatory Compliance Professionals for EU MDR & EU IVDR
Dedicated Team
We have a dedicated team specializing in Regulatory Affairs, Labelling, Regulatory Medical Writing, Regulatory Information Management, Pharmacovigilance, as well as Publishing and Submissions to meet the requirements of EU MDR (Medical Device Registration) and EU IVDR (In vitro diagnostics).
On-Time Access
We offer timely access to qualified professionals to support your ongoing regulatory affairs and operational requirements to meet short-duration tasks or long-term staffing goals.
Skilled Professionals
Our extensive network offers contract staffing for highly skilled professionals in regulatory, quality, and safety roles, ensuring you get the right expertise exactly when you need it. Whether it’s short-term projects, peak workloads, or specialized regulatory initiatives, our seasoned experts seamlessly integrate with your team to accelerate compliance and reduce hiring overhead.
Our Medical Device Staffing and consulting services includes:
- Registration Dossiers — For various geographies including India, LATAM, ASEAN, and the Middle East
- Medical Affairs and Medical Writing
- Post-Market Surveillance Staffing & PMS Report Support
- Periodic Safety Update Reports
- Change Notification Files — For design, manufacturing, or labeling updates
- Audit Support Documents
- Regulatory Strategy Documents — For market entry planning
- Promotional Materials Review
- Labeling and Artwork Reviews
- IFUs — Assessed, revised, and aligned with applicable regulatory standards
- UDI Database Maintenance and Submission- Mainly for large SKU volumes
- Technical Files — Structured to meet MDR and IVDR compliance
- Clinical Evaluation Reports (CERs)
- Technical writing and Document Updates
- Periodic Update of Post market and Clinical Documents
- Complete EU MDR / IVDR documentation support and Data Management
- Tripartite Agreements and Regulatory Contracts — Drafted in accordance with EU and MDSAP partner requirements
- Incident Reporting — Including preparation and follow-up
- Analysis and Updates of Risk/IFUs and other documents based on PMS data for EU MDR (Medical Device Registration) and EU IVDR (In vitro diagnostics) compliance
- Risk Management Files — Risk management plans, reports, and risk analysis documentation
- Trend Analysis Reports
- Audit and Gap Analysis Reports — For technical files and QMS documentation
- QMS and eQMS system integrations
- Quality Manuals and Policy Documents
- Device Master and History Records
- Complaint Handling Reports — Weekly reports that include detailed case reviews
- Providing temporary or project-based ISO 13485-trained professionals
- General Safety and Performance Requirements (GSPR) Checklists
- Remediation of documents
- Gap Analysis of Device File
- Usability Engineering File
- Device Master and History Records
- Complaint Handling Reports — Weekly reports that include detailed case reviews
get immediate staffing support through our flexible models
GenAI AIXelar Model Plus
Lead the way with intelligent AI-powered compliance solutions
- GenAI Bots to help you
- Custom AI for documentation
- Advanced AI-driven analysis
- Personalized training using AI
Part- Time Reg Support
For startups or SMEs seeking project-based or virtual regulatory support
- Basic document review preparation
- Assistance for regulatory submissions
- PMS and vigilance support
- Compliance updates and alerts
Full - Time Reg Support
Ideal for businesses needing continuous compliance and submission support
- All services in Part-Time Reg Support
- Detailed regulatory documentation
- Complete regulatory submissions
- Comprehensive PMS
Why Choose Morulaa for Regulatory Compliance Services?
Experienced Consultant
Free your team from regulatory burdens and stay focused on creating what’s next. Our expert team ensures your regulatory success with cost-effective, efficient solutions.
- 30+ countries (manufacturers over 30 countries)
- 10,000+ medical device SKUs, with a strong team of experienced professionals, including doctors and Ph.D. graduates.
Faster Review Time
AI-backed regulatory medical device registration specialist providing efficient documentation, timely decision-making, and support across different time zones to minimize disruptions and costs in line with EU IVDR (In vitro diagnostics). compliance standards.
- 24/7 (Support)
- AI (Powered)
Cost Effective Solution
- Specialists (Senior, Junior, and Coordinators), Subject Matter Experts (SME), Managers, Regulatory Strategists, Document Translators, Local Language Experts, and Client Call Experts — all working in compliance for Medical Devices, In vitro diagnostics, and Cosmetics.
- We operate globally, delivering project support across regions including North America, Europe, Asia-Pacific, the Middle East, Latin America, Oceania and Africa.
Flexibility
Our contractors are available for both short- and long-term assignments. Provide your regulatory staffing requirements, and we’ll manage the end-to-end process.
Talent
Whether your focus is on Clinical Strategy, CMC, Regulatory Labeling, or Commercial Compliance, Dennis Partners sources highly qualified professionals to support your interim staffing and consulting goals. Our Medical Device Staffing services can help meet your specific project demands, ensuring timely and compliant execution.
Ready to Accelerate Your Market Entry?
Morulaa Offers Smart Solution within Your Budget for Medical Device Registrations Support
We manage time-consuming medical device regulatory tasks to save you valuable man-hours, reduce costs, and eliminate the stress of product registrations — covering the entire lifecycle from Product Development and Registration (documentation and submission), to Approval (review and authorization), and Post-Market Maintenance (monitoring, updates, and support).
We help clients identify and onboard the right global regulatory talent precisely when needed, with services spanning the USA, Canada, South America, Europe, the UK, the Middle East, Africa, and Asia.
Contact our team of regulatory experts to discuss your specific requirements and learn how our Regulatory Compliance Services can support your medical device registration and compliance needs.