Medical Devices Regulatory — support unit
Medical Devices Regulatory — support unit (MDRu) is a regulatory consulting unit within Instituto Pedro Nunes that helps medical device, IVD, and Software as a Medical Device manufacturers obtain CE marking and FDA approval, serving 200+ companies across EU and U.S. markets.
- Company typePrivate
- Founded-
- HeadquartersCoimbra, Portugal
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Medical Devices Regulatory — support unit does
Medical Devices Regulatory — support unit (MDRu) is a specialized regulatory consulting unit embedded within Instituto Pedro Nunes (IPN), specifically inside the Laboratory of Automation and Systems (LAS), a Portuguese private non-profit technology and innovation institution headquartered at Rua Pedro Nunes in Coimbra. MDRu assists medical device manufacturers, in vitro diagnostic (IVD) companies, and Software as a Medical Device (SaMD) developers in obtaining CE marking under EU MDR/IVDR and approval from the U.S. FDA. Its service portfolio is delivered as professional services on a quote-based, scope-tailored engagement model and spans Global Markets regulatory strategy, ISO 13485 quality management system implementation, gap analysis, pre-clinical and clinical testing (EMC, usability per IEC 62366-1, KOL validation), clinical evaluation and biological evaluation reports, EUDAMED/SRN registration, and post-market surveillance.
The unit operates a hybrid go-to-market combining direct outreach to manufacturers, referral flows through clinical and academic partners (NOVA Medical School, ULS Coimbra / Hospital da Universidade de Coimbra), ecosystem collaborations with TÜV SÜD (notified body), TEF-Health, DigiHealthPT, EIT Health, and EATRIS, and thought-leadership activities via webinars, industry events, and the medicaldevices.ipn.pt website. Reported scale signals include 200+ companies supported, 250+ devices/SaMD certified, and 400+ trainees over the most recent three-year window, alongside 15+ years of regulatory experience. A small (~10-person) multidisciplinary team combines regulatory affairs with AI, cybersecurity, and robotics expertise, supported by ISO 13485 certification of MDRu itself. No revenue, funding, or investor data are disclosed.
Medical Devices Regulatory — support unit firmographics
Firmographics- Name
- Medical Devices Regulatory — support unit
- Legal name
- Instituto Pedro Nunes
- Website
- https://medicaldevices.ipn.pt
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Medical Devices Regulatory — support unit (MDRu) is a regulatory consulting unit within Instituto Pedro Nunes that helps medical device, IVD, and Software as a Medical Device manufacturers obtain CE marking and FDA approval, serving 200+ companies across EU and U.S. markets.
- Ownership category
- akta.pro rank
Medical Devices Regulatory — support unit industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Services-Health Services (8000)
- akta.pro primary industry
- Medical Device Regulators (HLAJADAC)
- akta.pro secondary industries
- Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited) (HLAGALAJ)
Keywords
Where Medical Devices Regulatory — support unit is headquartered
LocationHeadquarters
- HQ city
- Coimbra
- HQ country
- Portugal
- HQ region
- Europe
Offices1 record
Markets served
Medical Devices Regulatory — support unit business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Regulatory Consulting Services: Professional consulting services for medical device regulatory compliance, including regulatory strategy, documentation preparation, clinical evaluation, quality management systems, and post-market surveillance support.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Medical Devices Regulatory — support unit product offering
Product offeringCore offering
Medical Devices Regulatory — support unit (MDRu) provides end-to-end regulatory affairs consulting for medical device and IVD manufacturers, including global market access support (FDA approval, CE Marking), quality management system implementation (ISO 13485), gap analysis, pre-clinical and clinical testing and validation, and post-market surveillance. The unit specializes in Software as Medical Devices (SaMD) and AI-enabled medical devices, serving manufacturers from early-stage startups through established enterprises seeking EU and US market certification.
Product overview
Medical Devices Regulatory — support unit (MDRu) is a regulatory consulting services unit operated by Instituto Pedro Nunes (IPN) that provides comprehensive support for medical device certification. The offering consists of a unified portfolio of consulting services including regulatory strategy for global markets (FDA, CE Marking), quality management system implementation, gap analysis, testing and validation, post-market surveillance, and specialized reports (CER, BER). The services are delivered by a multidisciplinary team and are designed to guide manufacturers through the entire product lifecycle from development through commercialization.
Differentiator
Problem solved
Functional benefit
Products and services
- Global Markets Services (FDA, CE Marking)
- Quality Management System (QMS) Implementation
- Gap Analysis Services
- Test and Validation Services
- Post-Market Surveillance Services
- Clinical Evaluation and Biological Evaluation Reports (CER/BER)
- EUDAMED Single Registration Number (SRN) Registration
Quantifiable outcome
- Successfully supported over 200 companies in obtaining CE marking and FDA approval for more than 250 medical devices and SaMD products
- +1 more outcomes
Companies that use Medical Devices Regulatory — support unit
Customer profileNamed customers13 records
Segments4 records
Ideal customer profiles3 records
Medical Devices Regulatory — support unit technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Medical Devices Regulatory — support unit partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core, major and minor.
- NOVA Medical School (NMS) / NOVA CRUcorePartnership to strengthen ability to attract new partners or clients for medical device services. NMS supports companies during clinical research phase including design, planning, monitoring, and data analysis. Joint event organized on 28 June 2024 to demonstrate partnership functionality.
- TEF-Health (Testing and Experimental Facilities)coreTEF-Health establishes Testing and Experimental Facilities linking companies with hospitals for testing and demonstrating solutions, including ethical and data protection reviews, incubation, and market analyses. IPN's MDRu participates in presenting service catalogues and supporting SMEs with regulatory compliance.
- DigiHealthPTcoreDigital Innovation Hub part of the European DIH Network, focusing on AI and Cybersecurity in Health. Supports startups, SMEs, and public sector with digital innovation and adoption. MDRu participates in project presentations and service catalogue offerings.
- TÜV SÜDcoreLeading European notified body for CE marking certification of medical devices. TÜV SÜD Italy provides MDR and IVDR auditing services. Joint events organized to demonstrate regulatory and certification pathways to companies.
- Unidade Local de Saúde (ULS) / ULS-C (Coimbra)coreLocal health unit and Coimbra University Hospital providing clinical partnership for testing and validation of health technologies, clinical investigations, and KOL validation services.
- EIT HealthmajorEuropean health innovation initiative. MDRu participates in EIT Health Regulatory Pathways to Market Bootcamp, providing 8 hours of mentoring with experts and 60 hours of content for healthcare innovators.
- EATRISminorEuropean infrastructure for translational medicine, visible in MDRu's partner logos section.
- European CommissionminorEU institution supporting health technology initiatives and regulatory frameworks. Referenced in MDRu's partner section.
- AAL ProgrammeminorActive and Assisted Living Programme for age-friendly technologies. Referenced in MDRu's partner section.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Medical Devices Regulatory — support unit competitors and assessment
Company assessmentBroad incumbents
- TÜV Rheinland: TÜV Rheinland is one of the largest notified bodies for medical devices globally, providing CE marking, ISO 13485 certification, and regulatory consulting. It competes with MDRu for the same medical device manufacturer clients across the EU.
- Intertek: Intertek offers medical device testing, certification, and regulatory services including EMC and usability testing. Its service portfolio closely overlaps with MDRu's testing and validation offerings.
- Emergo by UL: Emergo by UL is a global medical device regulatory consulting and market access firm covering FDA, CE marking, and other jurisdictions, competing with MDRu for cross-border medical device commercialization engagements.
- TÜV SÜD: TÜV SÜD is a global notified body and testing/certification giant for medical devices (MDR/IVDR). It is both an MDRu partner and the dominant incumbent offering overlapping CE marking and FDA-related services at much greater scale.
- BSI Group: BSI is a major notified body for EU MDR/IVDR and a leading ISO 13485 certification body, offering regulatory consulting and product certification services directly comparable to MDRu's portfolio.
- DEKRA: DEKRA is a global testing, inspection, and certification organization with notified body status for medical devices. It provides CE marking, ISO 13485 audits, and regulatory advisory overlapping with MDRu's services.
Direct peers
- Medidee Services: Medidee is a European medical device regulatory and quality consulting firm specializing in MDR/IVDR compliance, clinical evaluation, and notified body interactions — a closely matched regional peer to MDRu.
- NAMSA: NAMSA is a medical device-focused CRO and regulatory consulting firm offering biocompatibility testing, clinical evaluation, and FDA/CE regulatory strategy — a direct competitor for MDRu's mid-market medtech clients.
- RQM+: RQM+ is a pure-play medical device regulatory and quality consulting firm specializing in EU MDR/IVDR and FDA pathways, directly competing with MDRu for the same startup and SME customer base.
- MDSS Consulting: MDSS provides medical device regulatory consulting, CE marking, FDA submissions, and ISO 13485 support, with a focus on small and mid-sized manufacturers — directly comparable to MDRu's positioning.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Medical Devices Regulatory — support unit social profiles
Digital presenceMedical Devices Regulatory — support unit financial estimates
Financial estimateRevenue estimate
Valuation estimate
Medical Devices Regulatory — support unit leadership team
Management profileNumber of profiles
Profiles6 records
Medical Devices Regulatory — support unit funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Medical Devices Regulatory — support unit M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Medical Devices Regulatory — support unit
What does Medical Devices Regulatory — support unit do?
Medical Devices Regulatory — support unit (MDRu) provides end-to-end regulatory affairs consulting for medical device and IVD manufacturers, including global market access support (FDA approval, CE Marking), quality management system implementation (ISO 13485), gap analysis, pre-clinical and clinical testing and validation, and post-market surveillance. The unit specializes in Software as Medical Devices (SaMD) and AI-enabled medical devices, serving manufacturers from early-stage startups through established enterprises seeking EU and US market certification.
Is Medical Devices Regulatory — support unit a public or private company?
Medical Devices Regulatory — support unit is a private company. It is classified as corporate owned and is currently operating.
When was Medical Devices Regulatory — support unit founded?
Medical Devices Regulatory — support unit was founded in -1. It employs 1 to 10 people.
Where is Medical Devices Regulatory — support unit based?
Medical Devices Regulatory — support unit is headquartered in Coimbra, Portugal, in the Europe region.
How does Medical Devices Regulatory — support unit make money?
One revenue line is on record: regulatory Consulting Services.
Who are Medical Devices Regulatory — support unit's main competitors?
Broad incumbents on record are TÜV Rheinland, Intertek, Emergo by UL, TÜV SÜD, BSI Group and DEKRA. Direct peers are Medidee Services, NAMSA, RQM+ and MDSS Consulting.
Does Medical Devices Regulatory — support unit have an API?
No public API is recorded for Medical Devices Regulatory — support unit.
What industry is Medical Devices Regulatory — support unit in?
Medical Devices Regulatory — support unit's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAJADAC, Medical Device Regulators, with a secondary code of HLAJADAF, Clinical Trials Authorization & Oversight (GCP). Its NAICS code is 5417 and its SIC code is 8000.