American Preclinical Services of Minneapolis, MN at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

American Preclinical Services

8945 Evergreen Blvd., 55433 Minneapolis, MN
Telephone +1 763 7177990
Fax +1 763 7172042

This company is co-exhibitor of
Minnesota Dept of Employment + Econ Dev Minnesota Trade Office

Hall map

MEDICA 2018 hall map (Hall 16): stand A18

Fairground map

MEDICA 2018 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.16  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Certification and testing of medical devices, quality assurance

Regulatory Services

APS offers comprehensive global regulatory consulting services for the medical device industry. APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to achieve timely medical device approvals and registrations. Our capabilities include:
  • Strategic regulatory planning
  • Pre - Clinical Studies Strategy and Testing
  • Pre-market approval application (PMA)
  • Investigational device exemption (IDE)
  • Pre-market notification (510k)
  • Humanitarian device exemption (HDE)
  • Humanitarian device (HUD)
  • Expedited Access Pathway (EAP) for medical devices normally subject to Premarket Approval (PMA) or De novo registration
  • FDA Device Registration and Listing
  • Device master files submissions
  • U.S Agent
  • Implementation of FDA eSubmitter electronic Medical device reporting (eMDR) establishment and implementation
  • Product development protocol (PDP)
  • Labeling Review
  • Interpretation of standards and guidelines
  • Preparation and representation at FDA advisory panels and regulatory agency meetings
  • Establishment Registration and device listings
  • Import/export certificates and registrations

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About us

Company details

Discover American Preclinical Services (APS)
APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing.

By utilizing our catalogue of services, which includes regulatory consulting, ISO10993 biocompatibility testing, analytical testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, you’ll be able to develop and conduct a powerful preclinical program.

Whether your company is a startup or an established industry leader, our experienced scientific staff has the expertise to meet your research needs and timelines.  Pilot and screening evaluations, feasibility and efficacy testing or ultimately GLP safety studies of the finished product, you will have industry experts to rely on every step of the way. 

We strive to deliver comprehensive, yet rapid service with the understanding that in product development, the only constant is change. We’ve tailored our processes, capacity, and customer service to keep up with today’s fast paced business cycles. APS will go from a quote to a ready to implement study design with your time lines in full focus.

Challenge us -- we will meet your challenge

Learn More About the APS Powerful Preclinical Program:
American Preclinical Services is a full-service contract research laboratory dedicated to preclinical testing of medical devices and biotechnology platforms. Here, we’re committed to providing clients a tailored powerful preclinical program that is “best-in-class”. 

Meet the American Preclinical Services Team:
APS’ preclinical research professionals have the expertise required to successfully design and execute your standard and custom preclinical studies. 

Tour the American Preclinical Services Facilities:
Conveniently located in the heart of the Minneapolis/St. Paul Medical Device Bio-Tech cluster, APS labs are USDA licensed, AAALAC and ISO17025 accredited. 

Access Quality Assurance, Compliance & Accreditation:
American Preclinical Services is your resource for a full range of preclinical services, with exceptional quality assurance, compliance and accreditation. 

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