Quality Management at Emmace
Discover how our ISO/IEC 17025 accredited laboratory and Quality Management System delivers reliable, traceable, and scientifically sound test data to support biological evaluation of medical devices and our customers’ compliance with the EU MDR 2017/745 and applicable standards, including the ISO 10993 series.
Emmace Consulting AB is an independent Contract Research Organization (CRO) located in Lund, Sweden. Emmace operates a testing laboratory accredited according to SS-EN ISO/IEC 17025:2018 by SWEDAC (Accreditation Number 10501).
In addition to the accredited testing laboratory, Emmace also operates a testing laboratory for pharma analytical services. Both laboratories operate under established quality management systems. The two laboratories and their respective quality frameworks are described below:
ISO/IEC 17025 Accredited Laboratory
Emmace operates an ISO/IEC 17025 testing laboratory, accredited by SWEDAC. The Quality Management System is structured around the laboratory’s processes, with a focus on impartiality, technical competence and traceability. The scope of accreditation includes testing according to the following ISO 18562 standards:
- ISO 18562-2: Tests for emissions of particulate matter
- ISO 18562-3: Tests for emissions of volatile organic substances
- ISO 18562-4: Tests for leachables in condensate (determination of released condensate volume)
Pharma Analytical Laboratory
Emmace also operates an analytical testing laboratory under a Quality Management System based on Good Scientific Practice (GSP). The laboratory is specialized for inhalers, nebulizers, and nasal devices. While these analytical services are outside the ISO/IEC 17025 accredited scope, they are performed in accordance with applicable pharmacopoeial standards and regulatory guidelines.
- Pharmacopeial Alignment: Testing procedures align with pharmacopeias, such as European Pharmacopeia (Ph. Eur. 2.9.18 /2.9.44) and US Pharmacopeia (USP <601> / <1601>) standards.
- Regulatory Support: Studies are designed to support regulatory submissions to the FDA, EMA, and MHRA, including Product-Specific Guidances (PSGs) for generic bioequivalence (ANDA).
- Methodologies Covered: Delivered Dose Uniformity (DDU/DUSA), Aerodynamic Particle Size Distribution (APSD / Cascade Impaction), Laser Diffraction, Spray Pattern / Plume Geometry, and Nebulizer Characterization.
How We Ensure Quality
Every study conducted at Emmace – whether accredited testing, exploratory R&D, or expert advisory – is built upon the following:
- Standard Operating Procedures (SOPs): Laboratory testing follows strictly controlled SOPs, ensuring method repeatability and operator consistency.
- Data Integrity & Traceability: All analytical equipment (including HPLC, Cascade Impactors, Spraytec, and particle counters) undergoes routine calibration, qualification, and maintenance. Raw data and audit trails are securely archived.
- Scientific Review: Key data and critical results are reviewed by scientists possessing decades of combined pharmaceutical industry experience.
- Continuous Quality Improvement: Emmace conducts regular internal audits and self inspections, management reviews, and SWEDAC surveillance assessments to maintain continuous compliance and operational excellence.
Client Audits
We welcome quality audits from existing and potential pharmaceutical and medical device customers.
Accreditation Details
- Accreditation Body: SWEDAC (Swedish Board for Accreditation and Conformity Assessment)
- Accreditation Standard: SS-EN ISO/IEC 17025:2018
- Accreditation Number: 10501
- Facility Location: Lund, Sweden
The accreditation certificate can be viewed here.
More information can be found on the Swedac website.