Get Certified, Boost Efficiency

The medical device industry is booming, but many companies lack the expertise they need to achieve certification for their products and processes. That's where we come in. Crakn works with medical device startups and established companies to design and implement quality systems that ensure compliance and boost efficiency. We help you select the best system for your company and avoid common pitfalls that young organizations often face.

Selecting the Right Quality Management System

There are many quality management systems out there, but we help you select and implement the best system for your organization. We analyze your research and development systems to help you avoid common issues a new company may face. Our team sets up EDMS to help you transition from manual to electronic record.  and integrates your new system with Salesforce or other current software packages.

Risk Management & Process Reviews

Managing risk is one of the biggest challenges for many medical device startups. Our consultants analyze your current processes and implement risk management procedures that lay a solid foundation for success. We give you access to a wealth of expertise and an extensive network of trusted vendors. With our help, you can be sure your processes are in line with all the latest regulations governing the industry. Our services are perfect for companies involved in making a wide range of medical products, including:

  • Pacemakers
  • Valves / Stents
  • Dialysis Grafts
  • Nasal Products
  • Spine & Orthopedic Products
  • Dental Devices
  • Urinary Catheter Systems
  • Bioabsorbable Products
  • Medical Virtual Products
  • Hydrogel / Aseptic
Dental Tools


 

Quality Systems Implementation:

  • CFR 820
  • FDB / FDA
  • ISO 

Quality & Regulatory Services:

  • Management Review
  • Management Representation

Certification Preparation:

  • ISO 13485
  • ISO 9001
  • ISO 17025

Quality Systems Auditing (Internal or Supplier):

  • ISO 13485:2003/2012, 2016
  • Host FDA/FDB
  • California Department of Public Health
  • Notified Body Audits
  • CMO
  • Vendor / Supplier
  • OEM

Safety Inspections / Training:

  • Safety Training
  • OSHA Training
  • OSHA Audits 

Quality System Training:

  • 21 CFR Part 820
  • cGMP (Current Good Manufacturing Practices)
  • ISO 13485
  • GDP (Good Documentation Practices)