Clinical Services Regulatory Services Compliance Services EDC and Staticstics Design and Validation

Services

Design & Validation Services for Medical Device Manufacturers

In the world of medical devices, expertise in biocompatibility, sterilization and validation is a prized commodity.  Alquest’s Design & Validation Services Group is home to thought-leading experts who provide strategic, money- and time-saving advice and support – all with an eye on regulatory expectations.  Alquest offers unmatched depth and breadth of expertise in this single resource.

 

Areas of Expertise

  • Biocompatibility

  • Toxicology

  • Materials science

  • Sterilization

  • Environmental monitoring and controls in production

  • General analytical chemistry

  • General microbiology

  • Process Validation

 

Common Assignments

  • Risk assessment: Alquest evaluates the biological risk associated with a product or material, as required by ISO 10993-1 (2009) and the EU Medical Device Directives. We look at predicates, materials, processes and composites to inform you of biological and toxicological hazards and regulatory implications, known and potential. We also recommend ways to mitigate risk, whether through testing, or by establishing the safety of the materials and process.
  • Test planning: Enter the device development stage knowing what tests you need first. Alquest performs an assessment of your situation and needs, then presents a testing "roadmap" that facilitates your planning, budgeting and fundraising.

  • Reality check: Obtaining competitive quotes for testing services is one thing. But are the tests are actually needed? Alquest can evaluate the necessity and appropriateness of your test plans and issue options or recommendations. Our interest is in seeing you do only what is necessary, cost-effective and timely.

  • ad hoc consulting:  Need a question answered, an issue researched, or advice on how to reply to the FDA about a biological safety issue? Alquest will furnish expert counsel on an hourly basis, or on retainer.

  • Crisis support: Either before or after an FDA inspection, 483 or warning letter, Alquest can assist you with preparation or an effective response from senior expert counsel.

 

Value to Clients

 

Clients value Alquest’s Design & Validation Services Group for several reasons:

  • Time and money: Alquest provides insights and strategic thinking that can eliminate months and many thousands of dollars from your development cycle. Laboratories sell tests. We evaluate the need for testing.

  • Regulatory compliance: We provide our clients with peace of mind knowing that our recommendations will meet the requirements of consensus standards, FDA guidances and international regulatory bodies.

  • Clarity: We provide clarity and context to complex materials safety issues.

  • Scale: Alquest’s support and counsel to every client is customized. We do only the work you need and no more. By working to scale, our clients save money.