Quality and compliance
Our certifications
Our certifications are the foundation for the highest product quality and patient safety. As a reliable partner in healthcare, we guarantee through strict quality standards and continuous monitoring that every Deltamedica product meets international requirements and lives up to your trust.
Quality management certificates
Our quality management certificates form the basis for safe and effective drug production. They document our unwavering commitment to the highest quality standards and patient safety in all areas of our business.
GMP Deltamedica 2025
Good Manufacturing Practice (GMP) is at the heart of our pharmaceutical quality assurance. This certification confirms that all our human medicines are manufactured under the strictest controlled conditions.
Significance for Deltamedica:
- Patient safety: Minimization of contamination risks and assurance of consistent product quality.
- Regulatory compliance: Fulfilment of all legal requirements for drug manufacturing.
- International marketability: Access to global markets through recognised EU GMP standards.
- Building trust: Strengthening trust among doctors, pharmacists, and patients.
Our GMP certification covers complete control of the manufacturing process—from raw material acceptance to production and delivery. Every step is documented, validated, and continuously monitored.
GMP vet. Deltamedica 2025
Veterinary GMP underscores our commitment to animal health through specialized quality standards for veterinary drugs. This certification follows the same strict principles as human GMP, but takes into account the specific requirements of veterinary medicine.
Special aspects of veterinary GMP:
- Special production requirements: Adapted procedures for veterinary active ingredients
- Animal species-specific formulations: Consideration of different physiological needs
- Regulatory specifics: Compliance with EU Regulation 2019/6 for veterinary medicinal products
- Cross-contamination prevention: Strict separation of human and veterinary production
Deltamedica's commitment:
With our veterinary GMP certification, we ensure that our veterinary medicines meet the same high quality standards as our human medicines in order to protect the health and well-being of animals.
DIN EN ISO 13485
Veterinary GMP underscores our commitment to animal health through specialized quality standards for veterinary drugs. This certification follows the same strict principles as human GMP, but takes into account the
DIN EN ISO 13485
ISO 13485 is the international gold standard for quality management systems in the medical device industry. This certification confirms our ability to consistently provide medical devices that meet both customer requirements and regulatory provisions.
Core elements of ISO 13485:
- Risk management: Systematic identification and assessment of risks throughout the entire product life cycle
- Validation of specialized processes: Documentation and validation of critical manufacturing steps
- Traceability: Complete documentation from raw material receipt to delivery
- Market surveillance: Continuous monitoring of product performance after market launch
Benefits for Deltamedica:
- Regulatory compliance: Compliance with EU medical device regulations (MDR/IVDR)
- International recognition: Global market access through globally recognized standards
- Improved risk management: Systematic approach to patient safety
- Operational efficiency: Optimized processes and reduced error rates
Deltamedica's quality promise:
The combination of German and English certification underscores our commitment to international cooperation and enables us to serve both local and global markets with the highest quality.
Manufacturing and wholesale licenses
Our manufacturing and trading licenses form the legal basis for all our pharmaceutical activities. They not only confirm our authorization to manufacture and trade in medicinal products, but also document our strict compliance with all legal requirements for the protection of public health.
Manufacturing license (German/English)
The manufacturing license pursuant to Section 13 of the German Medicines Act (AMG) is the state license for professional drug manufacturing in Germany and the EU. This license is only granted after the most rigorous examination by the competent state authorities and confirms that Deltamedica meets all requirements for safe and high-quality drug production.
Deltamedicas qualifications
Personnel requirements:
- Qualified expert in accordance with Section 14 AMG with appropriate pharmaceutical training
- Continuous availability and responsibility for all manufacturing processes
- Proven expertise and reliability of personnel
Technical equipment:
- Suitable and adequate premises for production, storage, and testing
- Modern facilities and equipment in line with the state of the art
- Validated manufacturing processes and quality control systems
International recognition
- The German-English version of our manufacturing authorization enables:
- EU-wide validity: Recognition in all EU member states through harmonized standards
- International cooperation: Facilitated communication with global partners and authorities
- Exportability: Proof of EU GMP compliance for third-country markets
Regulatory flexibility:
- Support with international approval procedures
wholesale license
The wholesale license pursuant to Section 52a of the German Medicines Act (AMG) authorizes Deltamedica to trade in medicinal products on a professional basis. It confirms our competence as a trustworthy partner in the pharmaceutical supply chain and guarantees the proper storage, handling, and distribution of medicinal products.
Our wholesale license stands for:
- Security of supply: Reliable delivery to the German and European markets
- Quality assurance: Strict compliance with all pharmaceutical quality standards
- Logistics expertise: Efficient and safe distribution of medicinal products
- Legal certainty: Full compliance with all regulatory requirements
Product-specific certificates
These certificates document the compliance of our products with European directives for medical devices and ensure their safe placement on the market.
EC declarations of conformity for DeltaMax products and BSS Deltamedica
The EC Declaration of Conformity is a self-declaration by the manufacturer that a medical device complies with the essential requirements of Directive 93/42/EEC (Medical Device Directive) and has been CE marked.
Application to our product lines:
- DeltaMax irrigation solutions: EC declarations of conformity document safe use in ophthalmic and urological irrigation solutions.
- BSS Deltamedica: Special declarations of conformity confirm compliance with the requirements for balanced salt solutions (BSS) for intraoperative irrigation.
EG-Zertifikat 93/42/EWG
The EC certificate in accordance with 93/42/EEC is issued by a notified body and confirms that a product has successfully undergone conformity assessment. For products in higher risk classes (IIa, IIb, III), external certification in accordance with Module D (production quality assurance) or Module H (full quality assurance) is required.
Advantages for Deltamedica:
- Market access and acceptance: CE-marked products are freely available for sale throughout the EEA.
- Increased confidence: External testing by independent notified bodies confirms the highest safety and quality standards.
- Regulatory certainty: Proof of correct implementation of all relevant standards and specifications.