Regulatory Consultancies & CROs
Add a defined ISO 10993 referral, subcontract, or coordinated specialist workstream while your firm retains the wider regulatory engagement.
Explore consultancy and CRO collaborationMedDev Advisory considers defined collaboration with consultancies, CROs, testing laboratories, independent specialists, development teams, and technical organisations where a clearly bounded relationship improves the work without blurring scientific responsibility.
MedDev Advisory is an independent, founder-led ISO 10993 biocompatibility consulting practice. A collaboration begins only when the audience, workstream, deliverable, communication path, commercial arrangement, and review boundary can be stated plainly.
Depending on the engagement, MedDev Advisory may receive a referral, accept a bounded subcontract workstream, or coordinate distinct specialist deliverables. Each party remains accountable for the work it owns.
Start with the relationship closest to your role. The two priority routes have dedicated pages because their handoffs, safeguards, and commercial models are materially different.
Add a defined ISO 10993 referral, subcontract, or coordinated specialist workstream while your firm retains the wider regulatory engagement.
Explore consultancy and CRO collaborationConnect laboratory-generated protocols and reports to independent biological-evaluation planning, evidence interpretation, and client documentation.
Explore laboratory collaborationExperienced regulatory, toxicology, quality, clinical, or scientific specialists can submit a profile for a future, clearly bounded workstream.
Explore Project-Based CollaborationDiscuss a defined biological-evaluation support layer where design, materials, suppliers, process changes, or technical files need ISO 10993 reasoning.
Discuss Biological-Evaluation SupportConsider a defined webinar, workshop, public technical resource, accelerator session, or research contribution with attribution, IP, independence, and fees agreed in writing.
Discuss a Technical Education CollaborationIf your organisation has a distinct, ethical role around medical-device evidence or documentation, describe the non-confidential need. Fit is assessed case by case.
Describe a collaboration needManufacturer or startup seeking direct project delivery? That is a client engagement rather than a collaboration route. Start with Services or discuss your device project.
The model is selected before work starts so contracting, client visibility, authorship, review rights, fees, and responsibility are not left ambiguous.
One party introduces a potentially suitable opportunity. Each party scopes, contracts, invoices, and remains responsible for its own work. Neither party speaks for or binds the other.
MedDev Advisory undertakes a written, bounded ISO 10993 component within a lead firm's larger engagement. Inputs, deliverables, visibility, fees, authorship, communication, and review rights are agreed before work starts.
MedDev Advisory and other contributors own distinct deliverables under a written responsibility map. Client ownership, document control, authorship, communications, fees, and review boundaries remain explicit.
Share the organisation type, proposed relationship, general device or documentation area, timing, and desired workstream—without uploading confidential files.
The possible fit, conflicts, scientific-independence safeguards, client visibility, and any need for an NDA or written disclosure are reviewed.
The lead party, contracting model, inputs, deliverables, authorship, communications, fees, review rights, and limits are documented before work begins.
Each contributor delivers and reviews only within the agreed scope. Changes, handoffs, and final ownership remain traceable.
Send the organisation type, proposed collaboration model, general workstream, timing, and preferred next step. I will confirm whether a focused discussion is useful.