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Additional Services
Along with our focused offerings in biocompatibility, toxicology, and test subcontracting, the experts at Groenakker provide concierge advisory services in a variety key technical fields.
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Sterilization
Every story has a beginning, sterilization is at the center of ours. While time has brought diversification in experience and expertise, sterilization is where it all began. With decades of hands-on experience validating sterilization processes & supporting ground-up facility builds, we’re confident we can support any of our client’s needs. Key areas of expertise include:
Ethylene Oxide
Development and validation of an ethylene oxide sterilization process (especially from scratch) is as much art as it is science. With extensive hands-on experience, participation in ISO 11135 standard committees, and management of sterilization vendors, we deliver success. From cycle development and validation protocols to execution, maintenance, and change management, Groenakker handles EO sterilization comprehensively, regardless of project scale.
Radiation
Ionizing radiation sterilization—via Cobalt-60, electron beam, or X-Rays—is a highly effective method. Our involvement in ISO 11137 standard committees and deep experience ensures thorough knowledge and reliable validation of radiation sterilization processes. Partner with us for efficient radiation sterilization validation and ongoing process management.
Steam (Moist Heat)
Steam sterilization remains widely used in healthcare, especially at point-of-care facilities. Gezellig Scientific excels in validating steam sterilization processes for industrial and end-user applications. Whether validating elastomeric stoppers for drug containers or developing end-user cleaning and sterilization instructions for medical devices, Gezellig provides expert support.
Design Assurance & Commercialization
We specialize in creating and deploying systems and processes that are as unique as your business. If you have historic files which are in need of remediation, or you're needing quality or risk management documentation to support a new product or launch, Gezellig Scientific has experience in design and development quality assurance to support you in conforming to ISO 13485, ISO 14971, EU MDR, and other global regulations. Quality and risk don't need to be headaches or afterthoughts with our agile approach and transparent process deployment.
Regulatory Documentation & Legacy Products
Regulatory requirements constantly evolve, creating challenges for manufacturers of legacy medical devices. Our experts partner closely with clients to reduce internal burdens, providing comprehensive solutions for remediation of technical documentation. We ensure you remain compliant, allowing you to focus on future growth while confidently supporting legacy product documentation.
New Product Development
Early engagement in product design is critical. Our multidisciplinary team—engineers, scientists, quality specialists, and clinical professionals—tailors support to your project's specific needs.
Clinical Evaluation
The EU Medical Device Regulation (MDR) has put a tremendous emphasis on clinical performance and benefit of new medical products along with maintenance of detailed post-market surveillance (PMS) data. The more general, lenient, ‘once-and-done’ approach of clinical evaluations associated with the Medical Device Directive (MDD) are a thing of the past for companies that are transitioning to the MDR (or hope to in the future). Documenting the clinical performance of your product and the benefit which it provides to the patient is key to any successful European registration under the MDR. Gezellig Scientific has a team of clinical professionals that are dedicated to meeting our clients unique needs in performing clinical evaluations. Whether you are in need of a single clinical evaluation for a product, or need help establishing systems to support ongoing clinical evaluations and clinical data gathering - Groenakker has the expertise to provide bespoke support.
Our team of Clinicians, PhD Researchers, and Biomedical Engineers provides comprehensive support to all Clinical Evaluation needs.
Our team of Clinicians, PhD Researchers, and Biomedical Engineers provides comprehensive support to all Clinical Evaluation needs.
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