Maven Profcon Services LLP is a medical device consulting regulatory company provides regulatory guidance to medical device manufacturers in Ecuador. We help our clients by providing turnkey project services such as quality system accomplishment, training, licensing, certification, and regulatory approval.
https://mavenprofserv.com/turnkey-projects/
3. Introduction
Medical devices being closely associated with human life are
highly regulated and hence it is important that they be
designed in the right way. Retrospective compliances usually
involve intensive retracing; and twice the effort and time
involved. Hence, it is essential that these activities be
proactively performed simultaneously with infrastructure
development.
4. Maven Profcon Services LLP is a medical device consulting
regulatory company that provides regulatory guidance to
medical device manufacturers. We help our clients by
providing turnkey services such as quality system
accomplishment, training, licensing, certification, and
regulatory approval.
5. The Turnkey Project Helpful Areas
Plant layout preparation and approval
Procuring manufacturing approvals
Providing options for service providers
Consultation for Regulatory aspects during design
and development
Quality management system
6. Whole technical file construction
Clinical evaluation
Risk management
Training and implementation
Post market activities
Testing services
Compliance & policies
Auditing Maintenance
Services
7. Benefits of Turnkey Projects
Group of expertise in Maven make sure that the
projects comply with all applicable standard and
regulatory guidelines.
It helps to set out a scope of those project and
results are represented very precisely and perfectly.
8. We also help manufacturers create the best
manufacturing layout adhering to environmental safety
standards, a compliant clean room where required, easy
man-material movement, machine installation
requirements and ultimately managing the product and
process quality requirements and user requirements.
9. Conclusion
We work on all the regulatory and technical hurdles faced
by the manufacturer and coordinate & communicate with
authorities and regulatory bodies. We closely work with
client to reduce the time and work force involvement
ensuring minimum financial involvements, hence reducing
project costing.
10. With a diverse team, expert in various aspects of medical
device development and working methodologically to
make the entire process smooth and error-free we cater
to the requirements of clients.