Must and Shall

We partner with your organization to ensure compliance with relevant regulations and standards for medical devices, pharmaceuticals, food and aeronautics manufacturers in the US and foreign markets by providing solutions tailored to meet your needs. Whether you operate within the realm of US Code of Federal Regulations (21 CFR Part 4, Part 11, Part 820, etc), ISO Standards and Notified Bodies (ISO 13485, ISO 9001, ISO 14971, IEC 62304, etc), or other regulated industries, we’ve got you covered.

Our team understands the complexities of the regulatory environment and the importance of staying ahead of the curve. We offer comprehensive services designed to streamline your processes, mitigate risk, and foster a culture of excellence within your organization.

Why Choose Must and Shall?

1. Expertise: Our team consists of experienced professionals with in-depth knowledge of regulatory frameworks and industry best practices.
2. Customized Solutions: We recognize that every business is unique and work closely with you to develop compliance strategies that align with your specific goals and objectives.
3. Efficiency: We leverage modern technology and proven methodologies to deliver efficient and effective compliance solutions, saving you time and resources.
4. Peace of Mind: With Must and Shall by your side, you can rest assured knowing that your compliance needs are in capable hands, allowing you to focus on your core competencies.

Whether you’re seeking assistance with Design Controls, Audits, Training, a submission, or ongoing support and guidance, Must and Shall is here for you. Contact us today to learn more about how we can support your compliance journey and ensure your success in the constantly evolving regulatory landscape.