Quality Assurance for Medical Technology: PAConsult Joins Life Science Nord
The DAkkS-accredited testing laboratory PAConsult joins the Life Science Nord network as an experienced partner for quality assurance and product safety. From its headquarters in Hamburg, the company provides direct regional support to medtech customers in meeting international regulatory requirements such as the MDR. Together with its specialized medical technology site in Ochsenhausen (PAConsult meditec), the laboratory offers tailored validation solutions from early-stage development to final market approval.
We are delighted to actively participate as a new member in the Life Science Nord cluster! From our headquarters in Hamburg, we support medical technology companies right here in the northern region. Our goal is to actively shape local collaboration and stand by manufacturers as a strong, reliable partner for product validation.
As a testing laboratory accredited according to DIN EN ISO/IEC 17025, we have stood for absolute precision, independence, and the highest quality standards for over 25 years. To bundle the best possible expertise for the healthcare sector, our Hamburg team works hand in hand with the experts at our specialized medical technology site in Ochsenhausen (PAConsult meditec). We guide companies from the early development phase through to final market approval to guarantee patient safety and efficiently fulfill international regulatory requirements, such as the EU Medical Device Regulation (MDR).
An Overview of Our Core Competencies:
- Packaging and Sterility Validation (ISO 11607): Testing of sterile barrier systems and primary packaging for seal strength, burst pressure, and integrity to ensure seamless contamination protection up to the point of use.
- Injection Systems & Combination Products (DIN EN ISO 11608-1): Design verification as well as testing of requirements and test methods for needle-based injection systems such as autoinjectors and pen systems.
- Transport and Environmental Simulation (ISTA & ASTM): Simulation of mechanical and climatic stresses (vibration, shock, extreme temperatures) in our modern laboratories to prove that medical devices survive global transport routes undamaged.
- Physical-Mechanical Functional Testing: Development and validation of customized testing methods for tensile, compression, and bending loads directly applied to the medical device to secure its mechanical reliability in use.
We look forward to personal exchanges at upcoming networking events in the North and a successful collaboration within the cluster!
Are you planning a new project or looking for support with the validation of your medical devices? Contact our experts directly at meditec@paconsult.de or visit us online at www.paconsult.de/en.
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