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.
Faster 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.
Genuine 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.
Real Patient Safety Improvement
Structured quality management genuinely reduces device defects and adverse events, not just paperwork compliance.
Nutraceutical Market Credibility
ISO 22000 gives supplement and functional food producers structured hazard control credibility with both regulators and consumers.
Hospital & Distributor Procurement
Hospitals and medical distributors increasingly require certified suppliers as a baseline procurement filter.
What 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.
- UASL Accredited CertificationOnce you pass your audit, your UASL-accredited certificate is issued — globally recognised, verifiable online, and accepted internationally.
- Healthcare-Specific Audit ExpertiseOur auditors understand medical device risk classification, health data sensitivity, and pharma-adjacent quality requirements — not generic templates.
Matching your healthcare business to the right standards
Common scenarios and the certifications that genuinely apply.
Medical Device Manufacturer, US Market
ISO 13485 is now essential, not optional, given its direct incorporation into FDA's QMSR since February 2026.
Connected/Software-Enabled Medical Device
ISO 13485 for the device itself, combined with ISO 27001 given data handling and connectivity risks in modern devices.
Telehealth or Health Records Platform
ISO 27001 for genuine, certifiable information security, alongside separate HIPAA compliance readiness work if serving US patients.
Nutraceutical or Supplement Manufacturer
ISO 22000 gives structured, HACCP-based hazard control credibility for supplements and functional foods.
Pharmaceutical Packaging Manufacturer
ISO 15378 (our dedicated pharma packaging standard) combines ISO 9001-style quality with pharma-specific GMP requirements.
Indian Device Manufacturer, CDSCO Pathway
ISO 13485 combined with existing FDA/EU MDR approval can unlock India's Predicate-Equivalence Pathway for faster CDSCO review.
Tell us what you actually produce and which markets you're targeting during your free consultation — we'll recommend based on your real regulatory obligations.
What's shaping healthcare & pharma compliance
Several developments are reshaping legal obligations across this sector.
ISO 13485:2016 is now directly incorporated by reference into 21 CFR Part 820, replacing the old FDA Quality System Regulation entirely. A new risk-based inspection programme has also replaced the old QSIT inspection technique.
Class C/D devices require ISO 13485-aligned QMS for CDSCO licensing, with the mandatory perimeter expanding across device categories.
Devices already approved by FDA or under EU MDR can bypass full Indian clinical trials, with CDSCO reviewing in 30 working days — ISO 13485 plus existing approval creates a genuine fast-track.
Software as a Medical Device (SaMD) and AI-enabled devices now need ISO 13485-aligned quality management systems under CDSCO's guidance.
If you manufacture medical devices for the US or Indian market, this regulatory landscape has moved significantly in the past 12 months. London Cert reviews your product against the current rule set, not an outdated regulatory picture.
How to get certified — step by step
A clear, predictable process from first call to certificate in hand.
Free Consultation & Regulatory Mapping
We identify which standards your product category and target markets genuinely require, and provide a fixed quote within 24 hours.
Documentation Preparation
We help you build quality management, risk management, and hazard analysis documentation scoped to your specific product/service.
Stage 1 & 2 Audit
Our auditors conduct document review and an on-site facility audit, including production controls and risk management processes.
UASL Certificate Issued
Your UASL-accredited certificate is issued, globally recognised and valid for 3 years with annual surveillance.
Healthcare & Pharma Certification Cost — Transparent Pricing
Fixed-price, all-inclusive packages. No hidden fees.
Cost depends on device/product risk classification, facility size, and which standards you select. Contact us for a personalised, binding quote within 24 hours.
ISO 13485 Only
- Full QMS documentation
- Stage 1 & 2 audit
- UASL-accredited certificate
ISO 13485 + ISO 27001 Bundle
Popular- Combined documentation approach
- Data security + device quality
- Significant cost efficiency
ISO 22000 (Nutraceuticals)
- HACCP-based hazard analysis
- Full FSMS documentation
- UASL-accredited certificate
Healthcare & Pharma Certification — Every question answered
The most-asked questions — straight, accurate answers.
ISO 13485 (Medical Devices Quality Management System) is essential, and since February 2026 is directly incorporated into US FDA regulation via the Quality Management System Regulation (QMSR), meaning it now carries genuine US federal regulatory weight, not just voluntary certification value. Manufacturers of connected or software-enabled devices should also consider ISO 27001 given increasing device connectivity and data handling.
Still have questions?
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