Innovative technology, regulatory compliance, and smart business solutions.

We offer on demand and scalable consulting solutions that are specific to your needs.

Design History File Remediation

DHF remediation can have a major impact on your organizations operations. Furthermore, if not completed properly the significant amount of rework that usually has to occur can have a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. Our engineering consultants have remediated many product files for combination products and medical devices that have passed FDA and CE related inspections.

Product Development

We can manage your product development project from concept to launch or piece us in as needed. If you’re starting a new project our talented team of engineers will help you translate your product idea into specific user needs and design input requirements that can be verified and validated in compliance with FDA and international regulatory requirements. Next, we generate concepts and prototypes for user feedback. Once your final concept is chosen we take it through our rigorous ISO 13485 development process by ensuring design controls, risk management, and configuration controls are implemented properly. If needed, we can manage your verification and validation strategy and finally your regulatory submission to ensure your product meets its regulatory requirements, intended use, and commercialization goals.

Project Management

If you’re looking for a project manager to help lead one of your new or existing projects, let us help. Our project managers specialize in using standard project management methodologies to ensure your project remains on schedule and budget. Our project managers have deep technical expertise in medical device and pharmaceutical product development along with excellent personal and communication skills. Some projects that we can help you manage are as follows:

  •     Design history file remediation
  •     New product development
  •     Design change control
  •     Manufacturing location changes
  •     Manufacturing line extensions
  •     Mold changes
  •     Regulatory responses (i.e. 483 warning letters, deficiency letters…etc.)

Design Controls

We have a solid track record with the application of ISO 13485 and CFR 21 Part 820 compliant design controls to the product development of medical devices and combination products, we have expertise with:

  • Design and Development Planning
  • Defining User Needs and Design Inputs
  • Concept and prototype development
  • Design
  • Change Control projects
  • Creating Trace Matrix documentation
  • Verification and Validation – Planning, Testing, Protocols and Reports

 

Risk Management

We have expertise in the application of ISO 14971 compliant risk management for medical devices and combination products, we can drive the execution of the following deliverables:

 

  • Risk Management Plan and Report
  • Design Failure Mode Error Analysis (DFMEA)
  • Process Failure Mode Error Analysis (PFMEA)
  • Use Error Risk Analysis (UERA)
  • Product Hazard Analysis (HA); and Clinical Risk Benefit Analysis (CRBA)

 

Human Factors

Human factors is very important in today’s medical device product development, leave it to us to help. We understand the regulation and the process, we know how to implement solutions that satisfy IEC/ISO 62366 and ISO/IEC 60601-1- 6 ed 3.0, we can help you with the following deliverables:

 

  • Human Factors (HF) Plan and Report
  • Creation of the Use Error Risk Analysis (UERA)
  • Human Factors testing planning
  • Integration of Usability into Product Design
  • HF Formative and Summative Plan, Protocols and Reports

 

Quality System Development and Remediation

We can help you create a Quality System from start to finish or remediate your existing quality system. We have the experience, templates, and systems to make sure your Quality System is ISO 13485 compliant.

Regulatory

We specialize in creating regulatory strategies and submissions so you can focus on growing your business, our regulatory consultants have global experience in Medical Devices, Pharmaceutical Products, and Combination Products, we can help you with the following deliverables:

  • Creation of regulatory strategy
  • Pre-submission meetings with FDA
  • CE Mark
  • NDA and ANDA Submissions
  • 510 (K) Submissions
  • Premarket Approval (PMA)

Quality

Our Quality Engineering consultants have the experience and knowledge to help you get your product to market and in compliance, some areas of expertise that we can help you with are as follows:

 

  • Creation of Quality Systems; ISO 13485, ISO 9001, and ISO 14971
  • FDA 21 CFR Part 820, 210, and 211;
  • Quality System and DHF Audits; 483
  • Warning Letters, and Deficiency Responses
  • Audit Preparation
  • Merger and Acquisition due diligence

Statistics

Applying statics correctly and efficiently is one of the biggest challenges in the medical device and pharmaceutical industry. Our consultants apply modern statistical techniques to your projects that are in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations. We offer statistical consulting in some of the following areas:

 

  • General Statistics
  • Sample Size Determination
  • Design Verification and Validation Sampling Planning
  • Process Validation
  • Quality Data Trending
  • Test Method Validation
  • Statistical Process Control
  • Design for Six Sigma

SBIR and STTR Non Dilutive Funding

If you are looking for a way to fund your existing small company or startup, SBIR funding can be a great non dilutive option for you.

 

We have raised millions of dollars in SBIR funding, we assist clients in developing high quality grant SBIR and STTR proposals in the medical device, pharmaceutical, and life science fields.  Clients work directly with our Grant Writing Specialists, who provide expertise in obtaining grant funding in the client’s technical field.  Our services include writing and submitting full proposals as well as critical scientific review and editing to increase the competitiveness of the grant applications.

 

Learn more about SBIR and STTR funding here (link to NIH, NSF)

General Business and Start Up Consulting

If you are starting or running a medical device or pharmaceutical startup our team can help make sure you have the right processes in place to succeed. Some areas we offer services in are the following:

 

  • Branding
  • Niche analysis
  • Customer/Problem validation
  • Profit and Loss statements
  • Budgets
  • Valuation models
  • Buy vs Make strategy
  • Manufacturing strategy

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