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How can I benefit from Quality Assurance Services?Quality assurance is a crucial part of any medical device process. When you’re providing a product or service, health care professionals expect you to deliver exactly what they need without any flaws or mistakes. Providing poor quality products can be extremely harmful to patients and medical personnel in addition to damaging your company’s reputation. Even if you are the expert at making the product you offer, it can still be easy to overlook potential problems from the user end. How can MEDIcept services benefit you? Here are just a few ways:

Identify possible flaws. It can be dangerous to release a product without testing it thoroughly. Failures can lead to personal injury or death. Regulatory agencies including FDA may even shut you down if your product is considered harmful. Don’t let your company join those ranks.

Ensure customer satisfaction. You should be confident in your professional products. By investing in QA services, you don’t have to second guess yourself. Satisfied physicians and patients lead to continued sales..

Prevent warning letters. Having a fully compliant quality system reduces the chances the FDA will present you with a warning letter. Warning letters have a direct effect on your ability to deliver products to your customers. Your competitors will use these compliance issues against you. Plus you will have to spend additional money repairing and correcting the non-compliance findings.

Prevent product recalls. Product recalls mean publicly announcing that your company made a mistake and injured patients. This can cost you customers and prevent prospective clients from choosing you in the future.

MEDIcept offers a wide range of Quality Assurance (QA) services to meet federal and international requirements, from Design Control to Validation, from Production Control to Complaint Handling and Corrective Actions. We can help you develop and implement the right quality assurance program for your company, ensuring that you meet FDA and ISO 13485 requirements.

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)

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The Latest News

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...

Medical Device Risk Management: An ISO14971 Update

In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental stages of the risk management process remain unchanged, there are some key modifications that medical device manufacturers should be aware of to ensure that they can successfully navigate the development, testing, and launching of...

Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes

For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation...