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Quality Assurance

Quality Assurance

Our services include:

  • Quality systems SOP documentation development
  • Complaint and MDR reporting
  • Quality system training
  • Quality supplier audits
  • Quality system audit & remediation
  • Risk management & mitigation
  • Retrospective design history
  • Outsourced Quality Assurance (OSQA)

From Design Control to Validation, from Production Control to Complaint Handling and Corrective Actions, we offer a wide range of quality assurance services to meet Federal and international requirements. We can help you develop and implement a right-sized quality assurance program to meet FDA and ISO 13485 requirements.

Design Control:

Quality AssuranceAre you having trouble with your design control system? Let us review it and show you where we can help. We can develop a process that is effective and fits your company's specific needs.

Does your product contain software? Ensuring compliance during software development can be very difficult. The FDA guidance documents are very specific; missing information will lead to compliance and regulatory submission problems.

Do you need to perform a Usability Study? We have human factor experts who can help with protocol development, implementation, FDA meetings, and report writing.

Do you have an upcoming ISO or FDA audit and want to confirm your compliance? Do you want to have a mock FDA audit or gap analysis to ensure your system and records are acceptable? We have conducted over 400 corporate quality system audits. We have the experience to show you where there may be problems and recommend solutions.

Outsourced Quality Assurance (OSQA):

You are a small, startup company, getting ready to launch your new product design. Your funding is in place and you have your concept prototypes. Your small team (an engineer and the marketing guy, aka President) can't wait to get this “breakthrough” product into the hands of the medical community … and FDA reminds you that you need to implement a Quality Management System (QMS) that complies with their Quality System Regulation (QSR).

Suddenly your funding seems to shrink as you think about the need to hire a full time Quality Assurance person to not only build the QMS, but to run it as well. Or hire a full time Quality Engineer to help with design control issues. Not a pleasant thought. We all know that many QA folks can fail to recognize the need for speed in emerging technologies and small companies. And an experienced QA professional will be expensive.

There is a quick, compliant, and cost effective solution to your dilemma. MEDIcept, an experienced consulting group in the Boston area, has developed a uniquely responsive OutSourced™ Quality Assurance Program. This program jump starts your QMS, with the required procedures and time-saving forms and checklists. And, helps you manage the system to keep pace with your product launch timelines.

The MEDIcept Team, with at least one of its consultants dedicated to you, will provide the QA management functions for your start-up company. Implementation of the OSQA program means that you do not have to hire a fulltime QA person: MEDIcept will manage your QA for a fraction of the cost of an FTE.

Visit the full OSQA web page here.

Supplier Qualification:

The FDA and ISO are looking to see that you have qualified your supplier. Simply stating that they are ISO certified, FDA registered, or work with that "large international medical device company" will not suffice. In many cases, critical suppliers must be audited. We can conduct audits to help you maintain compliance and ensure that compliant products are delivered to your company.

Having performed over 300 compliance audits, MEDIcept can be your supplier auditor, reducing overhead costs and ensuring compliance.

Training:

MEDIcept has trained well over 5000 industry personnel in Design Controls, Risk Management, and Quality Systems. We can train your personnel, too.