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Bosanski Product Development Support
Design controls, risk management, and technical coordination for MedTech product development — with QualityCert holding regulatory and project control, not necessarily the engineering work itself.
Built around how your organization actually works
QualityCert structures management systems consulting by organization type, because a manufacturer, a distributor, and a pharmacy carry very different regulatory obligations.
Coordinated design controls without in-house engineering overhead
QualityCert keeps regulatory and project control; specialist work can be subcontracted to the right partner.
QualityCert's product development support covers design controls, risk management, usability engineering, verification & validation planning, and technical documentation for CE marking and MDR readiness. This is deliberately not an engineering service — QualityCert doesn't claim in-house software, hardware, or lab capacity it doesn't have.
Instead, QualityCert coordinates the work: maintaining a network of external specialists and labs for the hands-on engineering and testing, while keeping regulatory and project control centralized so nothing falls between two organizations' responsibilities.
Our scope of support
- Design control system setup and a documented development plan
- Risk management file per ISO 14971
- Usability engineering per IEC 62366-1
How we coordinate
- Verification & validation planning and execution oversight
- Technical documentation for CE marking and MDR technical files
- Coordinating external specialist and lab partners on your behalf
Outcome
- A design history file ready for conformity assessment
- Access to the right specialist capacity without building it in-house
- Clear regulatory and project ownership from concept through market
Ready to build a system that works for your organization?
Tell us about your organization type and where you are today — we'll recommend the right starting point.
Book Intro Call