Working Principle

The relationship should make responsibility clearer.

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.

Scope and responsibility agreed in writing
Independent scientific judgment protected
Non-confidential first contact and conflict screening
Choose Your Route

Who MedDev Advisory Can Collaborate With

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.

Priority collaboration route

Regulatory Consultancies & CROs

Add a defined ISO 10993 referral, subcontract, or coordinated specialist workstream while your firm retains the wider regulatory engagement.

ReferralSubcontractBEP / BER
Explore consultancy and CRO collaboration
Priority collaboration route

Testing Laboratories

Connect laboratory-generated protocols and reports to independent biological-evaluation planning, evidence interpretation, and client documentation.

Evidence HandoffISO 10993Independence
Explore laboratory collaboration

Specialist Consultants

Experienced regulatory, toxicology, quality, clinical, or scientific specialists can submit a profile for a future, clearly bounded workstream.

Project-BasedDefined DeliverablesNo Job Promise
Explore Project-Based Collaboration

Product Development & Manufacturing Firms

Discuss a defined biological-evaluation support layer where design, materials, suppliers, process changes, or technical files need ISO 10993 reasoning.

Design InputsMaterial ChangeTechnical File
Discuss Biological-Evaluation Support

MedTech Education, Research & Innovation

Consider a defined webinar, workshop, public technical resource, accelerator session, or research contribution with attribution, IP, independence, and fees agreed in writing.

EducationResearchInnovation Programmes
Discuss a Technical Education Collaboration

Other Complementary Organisations

If your organisation has a distinct, ethical role around medical-device evidence or documentation, describe the non-confidential need. Fit is assessed case by case.

Defined ScopeConflict CheckIndependent Judgment
Describe a collaboration need

Manufacturer or startup seeking direct project delivery? That is a client engagement rather than a collaboration route. Start with Services or discuss your device project.

Engagement Models

Three Clear Ways to Work Together

The model is selected before work starts so contracting, client visibility, authorship, review rights, fees, and responsibility are not left ambiguous.

01

Referral Collaboration

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.

02

Defined Subcontract Workstream

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.

03

Coordinated Specialist Engagement

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.

Engagement Process

From Initial Fit to Defined Responsibility

01

Non-Confidential Fit Check

Share the organisation type, proposed relationship, general device or documentation area, timing, and desired workstream—without uploading confidential files.

02

Scope, Conflict & Independence Review

The possible fit, conflicts, scientific-independence safeguards, client visibility, and any need for an NDA or written disclosure are reviewed.

03

Written Responsibility Map

The lead party, contracting model, inputs, deliverables, authorship, communications, fees, review rights, and limits are documented before work begins.

04

Controlled Delivery & Review

Each contributor delivers and reviews only within the agreed scope. Changes, handoffs, and final ownership remain traceable.

Independence & Safeguards

Good Collaboration Has Clear Limits

What MedDev Advisory Can Provide

  • BEP and BER drafting, review, gap assessment, and remediation support
  • Risk-based endpoint strategy and evidence traceability
  • Chemistry-to-TRA evidence coordination within stated qualification boundaries
  • Defined EU MDR, FDA, or CDSCO biological-evaluation documentation support
Review the core consulting scope

What It Cannot Provide

  • Laboratory testing, regulatory-authority representation, or guaranteed acceptance
  • Transfer of manufacturer, laboratory, lead-firm, or specialist responsibilities
  • Undisclosed referral incentives or pressure toward extra testing
  • Toxicological value selection or acceptability conclusions without appropriately qualified toxicology review
Review trust and confidentiality safeguards
Not Sure Which Route Fits?

Describe the relationship, not confidential device details.

Send the organisation type, proposed collaboration model, general workstream, timing, and preferred next step. I will confirm whether a focused discussion is useful.