MANUFACTURERS
SechMed for
SechMed can work as an extension of your R&D and design capacity, providing scalable, ISO 13485-compliant engineering, risk management, and regulatory documentation support. Whether you need to expand upstream into earlier-stage development, handle design updates on cleared devices, or manage MDR reclassification work, we help maintain project momentum without increasing headcount or disrupting internal operations.
Our team brings decades of hands-on medtech experience from concept through clearance, giving manufacturers the confidence to say “yes” to more clients, take on complex technical work, and strengthen long-term relationships through added value and audit-ready documentation.
In short: SechMed helps manufacturers extend capability, ensure compliance, and protect both momentum and margin, all while enhancing your position as a trusted development partner.
SechMed Advantages
SechMed As Your Early-Stage Partner
We handle concept, feasibility, engineering development, V&V planning, and regulatory direction
Scalable R&D and Design Capacity
We slot in as an overflow or parallel development team to take on design, documentation, or project execution
No Hiring Delay or Permanent Hiring Needed
Instant access to experienced development engineers and regulatory specialists for short-term senior R&D bandwidth without increasing headcount
Assured Regulatory Compliance
All work performed under ISO 13485 and EU/FDA frameworks with right-first-time documentation
Support for MDR application & Up-Classification
We manage Technical Documentation updates required under EU MDR for legacy and reclassified devices
Design Changes
We can manage design changes on cleared devices, including regulatory submissions when required
Client Retention & Added Value
Joint offering strengthens your position in early-tolate development
Manufacturer Benefits
Extend Your Offering Upstream
You can say “yes” to earlier-stage clients you currently have to turn away
Immediate Capacity
Allows you to accept more client work withoutoperational strain
Momentum & Protected Margin
Progress continues without delay and capability scaled without adding fixed cost or long-term salaries.
Audit-Ready Documentation
Smoother design transfer and stronger customer confidence
Avoid Unexpected Compliance Burden
Keeps regulatory responsibility from shifting onto your manufacturing team
Compliance Without Disruption
Design changes are implemented without slowing internal design or manufacturing
Expanded Customer Relationships
You can offer additional coverage of the product lifecycle to your customer with our help
Let’s explore how SechMed can expand your development offering and strengthen your client pipeline