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OutSourced Quality Assurance

MEDIcept’s unique OutSourced™ Quality Assurance and Regulatory Compliance Program: a proprietary program of QA and Compliance management, wherein MEDIcept conducts QA and Compliance activities on behalf of your company to ensure that all quality performance and regulatory requirements are continually met.

WHY CHOOSE MEDICEPT’S OSQA™ PROGRAM?

COST EFFECTIVE — for a fraction of the cost that you would have to pay an in-house QA associate, including salary and benefits, you will get a QA expert to manage your Quality System, supported by the full MEDIcept team, helping to ensure that you have the right skills at the right time – whenever you need them. We bill our services on a monthly retainer, making it easier to budget.

TRUSTWORTHY — MEDIcept has built its reputation on years of providing the best in regulatory services for medical device companies. We work with FDA and with international regulatory bodies to ensure that your company and your device are represented at your best. We often teach at Quality and Regulatory professional organization workshops and conferences. You will sleep easier, knowing that you are in the good hands of trusted Quality and Regulatory experts.

ALL OUR CONSULTANTS HAVE BOTH A BREADTH OF QA EXPERIENCE AND YEARS OF EXPERIENCE IN THEIR FIELDS — our expert consultants have together worked 90 years in both the private sector and for FDA. We know how things get done in a regulated industry, and we know the people who can make things happen in all the right ways for you.

MULTIPLE LEVELS OF EXPERTISE AT YOUR FINGERTIPS — together we cover the gamut of QA/Regulatory needs — versus one QA person at a facility who usually has strengths in only a portion of QA areas. You will have access to the full MEDIcept team, so that when specific skills are required or when more than one individual is needed to resolve an urgent task, the appropriate resources will be made available to you. (Please refer to “MEDIcept’s Expertise” section, below.)

HOW DOES IT WORK?

MEDIcept will assign a staff member to serve as your point of contact: in effect your company’s Quality Assurance Manager.

Your MEDIcept QA Manager will schedule and lead all of your required Quality Management System programs to keep you operating in full compliance with applicable US and international regulations.

Your MEDIcept QA Manager will provide you with the expertise to ensure that your suppliers maintain a Quality Management System that will meet your requirements — reducing the potential for receipt of non-conforming materials and customer complaints once your product enters the market.

We will visit your site regularly, as needed, to update local hardcopy files and complete other tasks that require presence on-site. We will be there at your request through FDA inspections and Third Party Audits (for international approvals to market).

To maintain cost-effectiveness, many of the routine QA functions can be provided remotely: for example, we can conduct weekly CAPA and Complaint meetings via teleconference. Often we can propose and/or approve documentation changes through a secure FTP site, and we will be available to you as needed, to answer questions and resolve quality problems remotely.

DOES MEDICEPT OFFER OTHER QUALITY ASSURANCE or REGULATORY SERVICES?

If you have an existing Quality Management System, we can conduct a QMS audit to identify gaps in the existing system. With more than 400 audits performed by MEDIcept staff, we can provide an efficient yet thorough gap analysis at your facility.

Based upon the audit findings, MEDIcept personnel will suggest changes to your current quality system documentation — for compliance as well as for ease of use.

To help you get your products to market in a timely manner, MEDIcept provides personnel with proven success in writing regulatory submissions, including Technical Files for CE Marking your product, 510(k) and PMA submissions, and IDEs if required.

MEDICEPT’S EXPERTISE

  • Developing and writing Quality Manuals, policies and procedures (SOPs)
  • Risk analysis, including FMEA and FTA, and risk mitigation
  • Quality System training
  • Supplier Evaluation and Supplier Controls
  • Quality System audits and remediation (for the US, Canadian, European and international regulations for medical devices)
  • Design Control managements, including retrospective Design History
  • Complaint and CAPA Management, including management of Removals and Field Corrections
  • Technical File and FDA submissions writing
  • Production controls and process validations, including sterilization validations
  • Distribution and order processing controls
  • Management Reviews, and internal audits against USFDA QSR, Canadian CMDR, and EU MDD, and ISO 13485 requirements
  • Efficient Management Reviews, and USFDA QSR, ISO 13485 and CMDR (Canadian) audits
  • Complaint and CAPA Management, including management of Field Corrections and Removals

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