Healthcare and pharma businesses face genuinely high-stakes regulatory expectations across three overlapping needs: ISO 13485 for medical device quality management (now directly incorporated into US federal regulation via the FDA's QMSR), ISO 27001 for information security given the sensitivity of health data, and ISO 22000 for nutraceutical and health food manufacturers applying food-safety-grade hazard controls. London Cert Ltd is a UK-registered certification body — we conduct your audit directly and issue your certificate directly, globally recognised.
ISO 13485 Is No Longer "Just" a Certification
As of February 2, 2026, ISO 13485:2016 is directly incorporated by reference into US federal law — specifically, 21 CFR Part 820, replacing the old FDA Quality System Regulation (QSR) entirely. This is a genuinely significant shift: ISO 13485 compliance is no longer a voluntary market-differentiation choice for manufacturers selling into the US — it is now literally the applicable federal regulatory requirement, enforced through FDA's risk-based inspection programme.
For Indian medical device manufacturers, CDSCO's Medical Devices (Amendment) Rules 2026 similarly expect ISO 13485-aligned quality systems for Class C/D device licensing, and the Predicate-Equivalence Pathway allows FDA/EU MDR-approved devices to bypass full Indian clinical trials with a 30-working-day CDSCO review — making ISO 13485 certification a genuine strategic asset, not just a compliance checkbox.
Why ISO 27001 Matters for Health-Tech Specifically
Health data is among the most sensitive categories of personal information handled by any industry, and health-tech companies increasingly need to demonstrate structured information security management — particularly for connected medical devices, telehealth platforms, and health records systems. Critically, ISO 27001 is genuinely distinct from HIPAA: ISO 27001 is a certifiable, internationally recognised management-system standard we issue directly, while HIPAA has no official government-issued certification of any kind — HHS has said so explicitly. Health-tech companies serving US patients typically need both: ISO 27001 for a genuine, certifiable security credential, and separate HIPAA compliance readiness work (Security Risk Assessments, policies, safeguards) which is fundamentally different from certification.
ISO 22000 for Nutraceuticals and Health Foods
Nutraceutical, supplement, and functional food manufacturers sit at the intersection of pharma-adjacent regulatory scrutiny and food safety requirements. ISO 22000's HACCP-based hazard analysis framework applies directly to this category, particularly relevant given the close packaging and quality parallels with pharmaceutical products.
Who Needs Healthcare/Pharma Certification?
- Medical device manufacturers, at any device class, needing ISO 13485 for market access
- Health-tech companies (telehealth, health records platforms, connected devices) needing ISO 27001 for data security
- Nutraceutical, supplement, and functional food producers needing ISO 22000
- Pharmaceutical companies needing ISO 9001 or ISO 15378 for packaging (see our dedicated pages)
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Real value for healthcare & pharma businesses
Based on outcomes reported by healthcare businesses we've certified.
ISO 13485 = US Federal Compliance
Since February 2026, ISO 13485 is directly incorporated into FDA regulation — certification is now regulatory necessity, not just market advantage.
FDA QMSR AlignmentFaster CDSCO Predicate-Equivalence Pathway
ISO 13485 plus existing FDA/EU MDR approval can unlock a 30-working-day CDSCO review, bypassing full Indian clinical trials.
Faster Market AccessGenuine Health Data Security Credential
ISO 27001 gives health-tech companies a certifiable, internationally recognised security standard — genuinely distinct from HIPAA's lack of formal certification.
Certifiable StandardReal Patient Safety Improvement
Structured quality management genuinely reduces device defects and adverse events, not just paperwork compliance.
Patient SafetyNutraceutical Market Credibility
ISO 22000 gives supplement and functional food producers structured hazard control credibility with both regulators and consumers.
Consumer TrustHospital & Distributor Procurement
Hospitals and medical distributors increasingly require certified suppliers as a baseline procurement filter.
Procurement AccessWhat healthcare & pharma businesses say about London Cert
Verified reviews from healthcare businesses we've certified.
With ISO 13485 now part of FDA's actual regulation, getting properly certified became non-negotiable for our US market plans. London Cert got us there efficiently.
London Cert was clear that ISO 27001 and HIPAA readiness were different things we needed both of — no false promises about a "HIPAA certificate."
Our nutraceutical brand needed ISO 22000 to satisfy both our export buyers and give consumers real confidence in our supplement quality. Genuinely useful process, not just a badge.
Is London Cert's certificate genuine & accepted?
Here's exactly why London Cert certificates are real and globally accepted.
- UK-Registered — We Conduct Your Audit DirectlyLondon Cert Ltd is registered in the United Kingdom. Our own team conducts your full on-site audit, including production facility review — we don't just sell a certificate.
- Certificate Issued Directly by UsOnce you pass your audit, we issue your certificate ourselves — globally recognised, with no third-party accreditation body in the process.
- Healthcare-Specific Audit ExpertiseOur auditors understand medical device risk classification, health data sensitivity, and pharma-adjacent quality requirements — not generic templates.