Doc. no.BPT-CV-01
Revision13
Effective2026-10-05
StatusApproved
Change historySee footer ↓

Medical devices · Regulatory affairs · Based in Spain

Bernardo Plaza Trillo

Senior RA/QA · Outsourced PRRC · CISO

ISO 13485 MDR 2017/745 FDA PRRC CISO SaMD Healthcare AI

I help medical device manufacturers and importers bring products to market and keep them there, in the EU, the US and markets worldwide: quality systems, MDR and FDA compliance, and the post-market work behind a valid CE mark or clearance.

Based inSpain
LanguagesES · EN · PT
BackgroundElectronic Eng. · RA/QA
01 / About

I keep medical
devices compliant.

I'm a senior Regulatory Affairs and Quality Assurance consultant for medical devices, working with manufacturers in Europe, the US and beyond. I focus on quality systems teams can run day to day and keep audit-ready, not binders that live on a shelf.

I act as outsourced PRRC under Article 15 of the MDR for manufacturers and importers who need regulatory coverage without a full-time hire. I also work as CISO, connecting information security to the demands of connected medical products.

Earlier in my career I co-founded a medical device startup. We built it, certified it, and it didn't make it. I learned more from that than from most of what went to plan.

Formal roles
  • PRRC (Art. 15 MDR)
  • CISO
  • Senior RA/QA Consultant
  • ISO 13485 Internal Auditor
Also interested in
  • Healthcare AI & digital health
  • SaMD regulation
  • Space tech (investor)
  • Animal welfare
02 / Track record
Track record

What I've shipped, and what I've built for clients.

My own products
1
Startup co-founded
5
EU CE marks
5
US FDA clearances
11
Countries registered
For clients
8
QMS implemented
(ISO 13485)
8
ISMS implemented
(ISO 27001)
1
AIMS implemented
(ISO 42001)
0
Major NCs in audits
across every audit to date
Where my products are registered
Registered · 11 countries CE marked · EU Home · Valencia
World map: product registered in Taiwan, Colombia, Indonesia, Mexico, Peru, Philippines, Russia, Switzerland, UAE, United States, Argentina; CE marked across the EU. MexicoUnited StatesPeruColombiaArgentinaSwitzerlandRussiaUAEIndonesiaTaiwanPhilippines MexicoUnited StatesPeruColombiaArgentinaSwitzerlandRussiaUAEIndonesiaTaiwanPhilippines Valencia, Spain
03 / Experience
Where I've worked
2025
Dec → Now
HealthTech Community Valencia ↗
Co-founder
A non-profit connecting the healthtech ecosystem in Valencia. We run monthly events, bring people together, and support the local talent and companies building in the field.
Non-profitCommunity EventsHealthtech Valencia
2024
Jul → Now
Complear · Part-time
Senior RA/QA Consultant
RA/QA consulting focused on Software as a Medical Device. I support SaMD manufacturers through the full regulatory lifecycle: QMS design, risk management, MDR compliance and notified body preparation.
Outsourced PRRCISO 13485 SaMDAudits ES · PT · DE · FR · CH
2023
Jun → Now
iDoctus M3 Inc.
PRRC & Information Security Officer
Regulatory compliance and information security for an AI-powered medical platform. I manage the QMS, ISMS and AIMS under ISO 13485, ISO 27001 and ISO 42001, oversee technical documentation, and supervise the regulatory supply chain for a SaMD product built around AI.
MDRISO 13485 ISO 27001ISO 42001 SaMDAI
~2014
→ 2022
Medical device startup — co-founder
Regulatory & Manufacturing Manager
Co-founded and ran a medical device startup. Built the QMS from scratch, obtained CE marking and FDA clearance, and managed the supply chain and international market registrations.
Co-founderQMS design CE & FDASupply chain
Full profile on LinkedIn ↗
04 / Services
What I do
01
Regulatory Affairs & QMS
QMS implementation and maintenance, notified body audit preparation, risk management and post-market surveillance, across the full product lifecycle.
ISO 13485MDR 2017/745 Post-market
02
Outsourced PRRC
Person Responsible for Regulatory Compliance under Article 15 of the MDR, for manufacturers and importers who need proper coverage without a full-time hire.
Art. 15 MDROutsourced PRRC
03
CISO & Information Security
Information security policies, technical risk management and cybersecurity alignment for connected medical products.
CISOISO 27001 ISO 42001MedDev security
04
Healthcare AI & SaMD
Regulatory evaluation of AI health products and Software as a Medical Device, and integrating AI into clinical and regulatory workflows.
SaMDAI/ML MedDev Digital health
05 / Break room
Survive the audit

Sixty seconds, three lives. Catch the good documents in the technical file and tap the bad ones before the auditor sees them.

Score 0000 Time 60s Major NCs left ●●● Minor NCs 0/3 Best 0000
Technical file
Audit day · 60 s
The notified body is here.

Move the technical file to catch valid documents (+100). Tap anything sketchy to reject it (+50). File a bad document and that's a major NC. Reject a valid one and it's a minor. Three minors make a major.

File these
Signed SOPRisk file · ISO 14971PMS planDoC…
Never these
SOP_v3_FINAL_final2.docxPost-it signature…

Mouse or finger moves the file · ← → on keyboard · P to pause · your best score stays in this browser

06 / Contact

Let's talk.

If you need an outsourced PRRC, QMS support, MDR certification prep, or help evaluating AI inside a regulated product, get in touch.

✉ LinkedIn ↗ GitHub ↗
Send a message