The medical, pharma and cosmetics sector operates under one of the strictest regulatory regimes in the world. Each market demands different standards, each product requires separate certification. CBE has guided companies in the field for decades — and knows exactly which standards open which markets.
Why CBE for medical & pharma?
By product and target market — CBE will recommend exactly what's required
Quality management for medical devices
The leading international standard for medical-device quality management. Required before FDA clearance, CE Mark and Ministry of Health registration. Defines the quality framework across the entire product lifecycle.
GMP for the cosmetics industry
A GMP standard specific to the cosmetics industry. Mandatory for export to Europe and the USA. Covers manufacturing, quality control, storage and distribution of cosmetic products.
Food safety management
Required for nutritional supplements, functional food and para-pharmaceutical products. Defines a full HACCP framework and supply-chain control for product safety.
Medical data protection — US market
Mandatory for any company processing US citizens' medical data. Especially relevant for Digital Health, telemedicine and connected medical-device companies.
Information security in healthcare
An extension of ISO 27001 for healthcare. Defines specific requirements for securing medical information, patient records and health information systems.
Before choosing a standard, you need to know which market you're targeting. Here's the map:
Product registration at the Ministry of Health, Israeli Pharmacopoeia regulations, import approvals, standard mark.
510(k), PMA, FDA registration, HIPAA for medical data. The most stringent requirements in the world — CBE prepares you.
CE Mark, MDR 2017/745 (medical devices), IVDR, GDPR for patient data. Strict European regulations.
The first step is to identify which market you're targeting. Each market has a different regulatory pathway. CBE maps the right pathway and guides you from the very first step.
ISO 13485 is a management standard for medical-device quality. GMP is a manufacturing practice. Many markets require both. CBE will recommend what's required based on the product and market.
Yes. ISO 22716 (GMP for cosmetics) is required for export to Europe and the USA. In addition, ISO 22000 for product safety. CBE specializes in the cosmetics field.
A technical product dossier is the documentation required for regulatory approval — specifications, tests, declarations of conformity and more. CBE prepares complete product dossiers for every market.
ISO 13485 includes procedures for managing field events and reporting to authorities. CBE guides you in establishing FSCA processes and rapid reporting to regulators.
A product change may require resubmission for approval. CBE analyzes the change and advises whether a new approval process is required and its scope.
A structured process that leads to approval — with ongoing support afterward for regulatory updates and product changes
Product + target market = approval pathway. We map exactly what's required
Identify what exists and what's missing for regulatory compliance
QMS procedures, SOPs, technical product dossier and conformity declarations
Simulation before the certification body, FDA audit or CE inspection
Certificate / approval in hand + ongoing tracking of regulatory updates
"CBE guided us to ISO 13485 and then to CE Mark approval. They knew the regulatory requirements exactly — we saved months of independent work."
Baxter Healthcare
VP Regulatory Affairs
"As a cosmetics company wanting to enter the European market, CBE led us to ISO 22716 in a professional and orderly process. Today we export to 12 countries."
Israeli cosmetics company
CEO
"We developed a Digital Health platform. CBE guided us to simultaneous compliance with HIPAA, ISO 27799 and GDPR — three different standards, one professional guide."
Digital Health company
CTO
Consultation call — free and no obligation — CBE will map the right approval pathway for you
A quick guide to choosing the right certification pathway
| Product type | Israeli market | US market | European market |
|---|---|---|---|
| Medical devices | ISO 13485 + Ministry of Health | ISO 13485 + FDA 510(k) | ISO 13485 + CE/MDR |
| Drugs / Pharma | GMP + Ministry of Health | GMP + FDA | GMP + EMA |
| Cosmetics | Israeli cosmetics regulations | ISO 22716 + FDA OTC | ISO 22716 + EU Cosmetics Reg. |
| Nutritional supplements | ISO 22000 + Ministry of Health | ISO 22000 + FDA DSHEA | ISO 22000 + EFSA |
| Digital Health / AI | ISO 27799 + HIPAA | HIPAA + FDA SaMD | MDR + GDPR + AI Act |
Much of the work can usually be done in parallel — ISO 13485 is valid for both markets. CBE builds an integrated plan that saves time and cost.
Tell us about the product and target market — we'll come back with the right regulatory pathway