Quality and Regulatory Compliance Services

To be able to market devices in the US or any other country, medical device manufacturers must have an established quality system. In the United States, all manufacturers of medical devices must be complaint with FDA's quality system regulations (21 CFR part 820). Furthermore, depending on business needs, medical device companies may need to establish quality systems that meet standards such as ISO 13485, or comply with government agencies such as JPAL, or Health Canada. Our consultants have decades of experience with these requirement and can help your company meet these requirements. The following are a few of the services we provide:

  • FDA Mock Audit
  • Internal Audit (training and visits)
  • 3rd Party Audits (suppliers and contract manufacturers
  • Regulatory and Quality Due Diligence Audits
  • ISO 14971 (Risk Management)
  • Pre-assessment Notified Body audits
  • CAPA
  • FDA Inspection 483 Responses
  • Warning Letter Responses
  • JPAL

US Regulatory Services

Our consulting services help medical device manufacturers, including IVD manufacturers. Some of the services we provide could be critical in getting your device to market. If you are a new company, we can map out a regulatory strategy that will provide insight into the regulatory challenges you will face. One of these challenges might be the need for a Quality System that is compliant with 21 C.F.R. part 820. Fortunately, our consultants have decades of experiences establishing and maintaining such systems. Other services we provide include writing and submitting regulatory submissions (510(k)s, 513(g)s, etc.) and responses to the FDA.

  • 510(k)
  • 513(g)
  • Refuse to Accept (RTA) Responses
  • Additional Information Request (AI)
  • Pre-Submissions (Q-Sub)

International Registration Services

International Registrations are often times critical in growing a business. One strategy often taken by medical device manufacturers is to market their products outside the United States before gaining marketing approval domestically. Other companies generate significant revenue by expanding their market internationally after first marketing their products in the US through the FDA process. Given your company’s needs, our consultants can help guide you.

CE Marking Services

To gain market approval in the European Union, medical device manufacturers must obtain a CE mark on their products. Obtaining this mark means your company complies with the regulations outlined in the applicable EU Directives and that your quality system meets the requirements of ISO 13485. Our consultants have extensive knowledge and experience with the CE Marking Process and can assist your company with your needs.