Device market access
EU MDR, FDA and other regulators expect a compliant QMS.
How we help: ISO 13485:2016 with design, risk and post-market processes regulators recognise.
Industry
Healthcare & Life Sciences
Device makers, laboratories, hospitals and pharmaceutical companies answer to regulators and patients. We build quality, laboratory and information systems that support regulatory approval and stand up to inspection.
Challenges we solve
Pressures on healthcare organisations
Regulatory approval, patient safety and data protection meet in the same quality system.
Laboratory accreditation
Accreditation for clinical and testing laboratories.
How we help: ISO 15189:2022 and ISO/IEC 17025 accreditation readiness.
Patient data
Health data protection and cyber threats.
How we help: ISO/IEC 27001 and ISO/IEC 27701 for security and privacy.
Supplier qualification
Device makers require certified suppliers.
How we help: ISO 13485 scoped to the components and services you supply.
Facilities
Hospital estates and critical services.
How we help: ISO 41001 facility management and ISO 22301 continuity.
AI in clinical tools
Decision support and imaging AI under scrutiny.
How we help: ISO/IEC 42001 governance for AI systems.
Recommended standards
Standards for healthcare and life sciences
Core standards first, then the additions your customers, regulators or risks call for. Most run as one integrated management system.
ISO 13485
Medical device quality management.
Core ISO 15189Medical laboratory accreditation.
Core ISO/IEC 17025Testing laboratory accreditation.
Core ISO/IEC 27001Patient and research data security.
ISO/IEC 27701Health data privacy.
ISO 9001Quality for non-device services.
ISO 41001Hospital facility management.
ISO/IEC 42001AI governance for clinical tools.
Regulatory context
Requirements that shape your system
Management systems help you meet these obligations and show evidence of control. They do not replace the obligations themselves.
Medical device regulation
EU MDR and IVDR, and the US FDA Quality Management System Regulation, which incorporates ISO 13485:2016 from February 2026.
Laboratory rules
National requirements for clinical laboratories and accreditation.
Health data protection
Data protection law covering health data, such as GDPR and HIPAA.
Pharmaceutical quality
Good manufacturing and distribution practice requirements where they apply.
Which requirements apply depends on your jurisdiction and activities. We map your system to the ones that apply to you.
How we work with healthcare and life sciences
One partner, gap to certificate
01
Consultancy
Gap assessment, implementation and integrated systems built around how healthcare and life sciences operations really work.
02Certification support
Certification body selection, mock audits and Stage 1 and Stage 2 support.
03Training Academy
Awareness to CQI/IRCA Lead Auditor, in-house or public.
04Ongoing partnership
Outsourced internal audit, management review and 2026 transitions.
Experience
Healthcare & Life Sciences work we have delivered
Healthcare & packaging · USA
DuPont Spectrum
ISO 13485:2016 · 2021 · 13 sites in 10 states
1stAttempt
0Major NCs
13Sites
The challenge
Bringing 13 sites under one medical-device quality system, with demanding design, purchasing, complaints and CAPA records and a complex supply chain.
What AEC did
Multi-site gap assessment, harmonised documentation, design, purchasing, complaints and CAPA processes, supplier qualification, risk management, training and multi-site internal audits.
Certified at first attempt, no major nonconformities. Opened access to medical device makers that require certified suppliers.
Selected clients in this sector: Sanofi, Merck KGaA, Ipsen, Pharming, DSM. Names and trademarks belong to their owners and indicate client relationships only.
Training Academy
View the Training Academy
Training for healthcare and life sciences teams
CQI/IRCA Approved Training Partner. Awareness, Implementer, Internal Auditor and Lead Auditor courses, in-house, public, virtual or hybrid.
Popular courses for this sector: ISO 13485, ISO/IEC 17025, ISO/IEC 27001, ISO/IEC 27701.
Questions
Healthcare & Life Sciences FAQ
Does AEC issue the certificates?
No. Certificates are issued by independent certification bodies accredited by UKAS, DAkkS or an equivalent national accreditation body, or by the scheme-specific bodies some standards require. AEC prepares your organisation for those audits.
Does AEC accredit laboratories?
No. Laboratories are accredited by national accreditation bodies. AEC prepares you for ISO 15189 or ISO/IEC 17025 assessment.
Is ISO 13485 enough for FDA?
The FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference, with some additional requirements. A system built to ISO 13485 is the foundation; we map the additions.
Plan your healthcare quality system
Tell us your products, laboratories or services and your regulators. We reply with a proposal covering implementation and certification or accreditation readiness.
Certification decisions are made by independent, accredited certification bodies. AEC prepares organisations for certification and does not guarantee certification outcomes.