Partner With Qualisure
We work with independent specialists and consultancies who share our standards, giving medical device and IVD manufacturers deeper expertise with one accountable point of contact.
About Qualisure Consulting
Qualisure Consulting is an Oxfordshire-based specialist in medical device quality management and regulatory affairs. Led by Carlos Maline, a former BSI auditor, we help manufacturers achieve and maintain ISO 13485 certification, prepare for MDSAP, comply with UK MDR, EU MDR 2017/745 and IVDR 2017/746, and act as UK Responsible Person (UKRP) for overseas manufacturers.
Service Portfolio
Our four core service lines. Select a service to see the scope.
QMS Auditing
Internal and supplier audits against ISO 13485 and ISO 9001, identifying gaps and supporting continuous improvement.
- Internal audit programmes and certification readiness
- Supplier and critical-subcontractor audits
- CAPA effectiveness and audit follow-up
Regulatory Services & UK Responsible Person
End-to-end support for technical documentation and risk management under UK MDR, EU MDR and IVDR, including preparation and review.
- UKRP appointment, MHRA registration and ongoing UKRP obligations
- Technical documentation preparation and review
- ISO 14971 risk management and post-market surveillance
MDSAP Preparation
Readiness support for the Medical Device Single Audit Program, tailored for one, two or multiple jurisdictions.
- Jurisdiction-specific gap assessment
- Mock MDSAP audits
- Remediation planning
Regulatory Training
Accessible, online modular workshops.
- ISO 13485 and ISO 14971
- EU/UK MDR and FDA regulations
- Use of AI in regulatory affairs
Partnership Model
As UK Responsible Person and quality partner to our clients, Qualisure keeps accountability for every deliverable. Partners bring specialist depth on clearly scoped work.
What Qualisure brings
- UKRP accountability and the client relationship
- UK MDR and MHRA regulatory context
- Notified Body-style audit and review methodology
- Final review, sign-off and client communication
What partners bring
- Specialist expertise, currently IVD and EU IVDR
- Evidenced technical review experience
- Capacity for defined work packages
- Commitment to confidentiality and independence
Partnership Opportunities
Typical work packages for partners. Select each to expand.
How We Would Work Together
Select a stage for detail.
1 Scope: Qualisure confirms scope and issues a work order. 2 Access: documents shared securely under mutual NDA. 3 Review: partner reviews using Qualisure templates. 4 QC: Qualisure verifies findings. 5 Deliver: Qualisure issues the final report and retains UKRP accountability.
Working Principles
| Area | Principle |
|---|---|
| Client relationship | Clients remain Qualisure clients; no direct solicitation during the engagement and for an agreed period afterwards. |
| Confidentiality | Mutual NDA before any client information is shared; client-specific confidentiality terms flow down. |
| Data protection | UK GDPR-compliant handling and international transfer safeguards where personal data is involved. |
| Independence | Declaration of no conflicts of interest for each assignment. |
| Quality | Qualisure templates, severity grading and final review; reviewer qualification records maintained per ISO 13485 competence requirements. |
| Commercials | Fixed fee per work package or agreed day rate, set out in each work order. |
Becoming a Partner
- Send a short introduction, CV and summary of relevant device or IVD experience
- Introductory call to discuss fit
- Mutual NDA and competence evaluation
- Pilot review, then framework subcontractor agreement
carlosmaline@qualisureconsulting.com · +44 7403 979256 · Oxfordshire, UK