Quality assurance (QA) is a crucial part of any medical device manufacturing and assembly 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’re the expert at making the product you offer, it can still be easy to overlook potential problems from the user end.
How can MEDIcept quality assurance 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 the 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. In addition, 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 possibly 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 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)