Biomedical Analysis
As materials and technologies advance, the biomedical industry is experiencing a convergence of technology, pharmaceuticals, medical devices and diagnostics for improved treatments and therapies. Eurofins EAG Laboratories offers biomedical analysis services to evaluate the materials, chemistries and components in the latest products.
From surface chemistry to physical properties, we have established ourselves as the premier scientific services company with expertise in biomedical products, chemistries and materials, regulatory insight and a proper sense of urgency to deliver meaningful results with an impact.
EAG’s team of scientists has a passion for developing appropriate scientific studies to provide insight and solutions to the latest technical problems. Our laboratories are equipped with numerous pieces of state-of-the-art instrumentation and equipment to ensure reliable results and minimize the chance for down time.
Biomedical Analysis Examples
These tools provide understanding for:
- Surface chemistry of biomedical products
- Polymer chemistry of biomedical products
- Microscopic structure and morphology
- Nickel biocompatibility
- Part 18 chemical characterization
- In vitro biocompatibility
Our customers value the scientific interaction they receive during project scoping and discussion. Please call us at 800-366-3867 or complete the ASK AN EXPERT form to speak with one of our scientists about your biomedical analysis challenges.
Biomedical Analysis: Chemistry and Materials Expertise
Pharmaceuticals, medical devices and diagnostics utilize a complex set of chemistries and materials to ensure efficacy of the product in addition to patient safety. Examples have included development of critical surface chemistries to improve device stability and biocompatibility, drug substance stability on an intradermal delivery system and diagnostic testing on a chip.
EAG Laboratories has experience in a variety of chemistries and materials including:
- Polymer chemistry
- Metallurgical alloys
- Nitinol
- Coatings and Adhesives
- Plastics
- Hydrogels
- Glass
- Surface chemistry
- Ceramics
- Electronic components
- Biomolecules
Our scientists and engineers have access to a diverse set of analytical instrumentation to serve as an extension to your analytical R&D group, including:
Biomedical Method Development & Validation
EAG’s chemical testing services excel at novel analytical biomedical method development using advanced instrumentation and specialized sample preparation techniques. EAG is able to leverage years of diverse analytical experience in many different industries to meet a client’s specific testing need.
EAG can systematically develop incredibly detailed and complex protocols that can stand up to the intense scrutiny of an external auditing organization or quickly adapt our vast knowledge and capabilities to rapidly institute a novel testing method. Below is the basic framework of EAG’s method development approach.
With biomedical method development at EAG, customers have access to our technical expertise as well our conclusive report that documents the steps in the method development process as well as the final results of the analysis.
EAG can systematically develop incredibly detailed and complex protocols that can stand up to the intense scrutiny of an external auditing organization or quickly adapt our vast knowledge and capabilities to rapidly institute a novel testing method. Below is the basic framework of EAG’s method development approach.
- Identify the technical challenge
- Decide on the analytical approach
- Develop sample preparation techniques
- Generate a protocol or plan
- Execute methodology and refine
- Deliver results
With biomedical method development at EAG, customers have access to our technical expertise as well our conclusive report that documents the steps in the method development process as well as the final results of the analysis.
Biomedical Analysis Requires Regulatory Insight
We are in an ever-increasing world of regulatory oversight, which continues to become involved earlier in the development process. While this can help the regulatory submission process later in the development cycle, as well as provide valuable insight during investigations, too much regulatory control can also hinder innovation. The biomedical and pharmaceutical development engineers and scientists are consistently weighing the needs of regulatory and testing that can answer complex scientific questions relating to materials used in products.
Want to learn more about the appropriate regulatory standards for outsourcing analytical projects to support medical device development?
EAG Laboratories understands those needs and has built laboratories on a strong foundation of quality as well as developed the technical advising staff to understand the development cycle and what regulations apply. Our large-scale, comprehensive QC program guarantees standard calibration procedures, validated methods and third-party audits.
We carry ISO 17025 Certification at most of our Materials and Engineering Sciences laboratories. We also have supported standards organization such as ISO and ASTM in the development of those standards used in regulatory submissions, as well as providing the necessary data to help notified bodies write guidance defining what is needed to have a successful submission. EAG’s technical advising staff also knows when certain regulatory requirements are needed. They can foresee where the regulatory requirements will apply and provide options to the development engineers and scientists to design a more perfect study that could save time and money long term.
Whether you are early in the development process and evaluating new materials/process, or need support in the validation/verification process, or are gathering the necessary characterization on the materials for your biocompatibility assessment, or are evaluating a failure investigation, EAG KNOWS HOW and when to apply the appropriate regulatory requirements.
Related Resources
- Webinar: Compatibility of Polymers in Medical Devices
- App Note: Corrosion of Electropolished Medical Devices
- App Note: Contact Lenses: Understanding Surface Chemistry
- App Note: Stainless Steel Corrosion: Medical Device with AES
- App Note: Adhesion Failure in Medical Device Packaging
- App Note: Residual Solvents in Medical Devices
- App Note: GMP, GLP or ISO 17025: Analytical Testing
- App Note: Nickel Exposure of Intravascular Stents
- Blog: Incompatible Contaminant in Tubing
- Service: Part 18: Chemical Characterization of Materials
- Industry: Medical Devices
- Industry: Pharmaceuticals
- Industry: Generic Drugs
- Industry: In Vitro Diagnostics
Sense of Urgency
As a premier scientific services provider, we recognize the importance of delivering results and answers to critical questions within a time frame to make an impact. We foster a proper sense of urgency with our scientists and engineers, accomplished by:
- Capital Resource Management: In most cases within EAG, we have multiple pieces of instrumentation for our variety of techniques. This allows us back up instrumentation in the event an instrument is out of service. Additionally, the multiple pieces of equipment increase our overall capacity for throughput, thus allowing us to deliver results within a reasonable timeframe.
- Efficient Scientific Services Process: We have developed a proprietary, in-house LIMS system that allows for efficient sample management and throughput in the lab.
- Lab Culture: Our scientists embrace an efficient lab culture and are passionate about delivering results to make a meaningful impact.
Additional Support
Eurofins EAG Laboratories also offers manufacturing consulting and advisory services including expert witness testimony, and intellectual property support.
Typical Biomedical Analysis Techniques
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