OpenRegulatory
OpenRegulatory is a company that specializes in regulatory compliance services for medical device startups, offering workshops, software solutions, and various support services to streamline the compliance process.
Regulatory Strategy Workshop
OpenRegulatory offers a Regulatory Strategy Workshop specifically designed to help startups navigate the complex regulatory landscape before starting product development. This workshop aims to set the foundation for a compliant product journey by guiding companies on regulatory pathways and considerations critical to their success. It is an essential service for startups looking to align their products with regulatory requirements from the outset.
Headstart Program
The Headstart program from OpenRegulatory provides a comprehensive solution to help medical device companies bring their products to market efficiently. It includes a suite of videos, document reviews with weekly meetings, and regulatory software aimed at streamlining the compliance process. This structured program ensures that companies receive ongoing support and tools necessary for successful regulatory submissions.
Formwork Regulatory Software
OpenRegulatory's Formwork is a purpose-built regulatory software designed to simplify and automate compliance tasks for medical device companies. This software helps organizations manage documentation, streamline processes, and ensure adherence to regulatory standards, reducing the time and effort required for compliance activities.
Document Review and Internal Audits
OpenRegulatory provides document review services to advise companies on potential audit findings and suggest efficiency improvements in documentation. Additionally, they conduct internal audits as required by ISO 13485 for medical device companies, including preparation and audit report writing. These services help companies maintain compliance and identify areas for operational improvements.
Custom Regulatory Support
OpenRegulatory offers tailored regulatory support for various tasks not explicitly listed, such as writing documentation, resolving audit findings, closing Corrective and Preventive Actions (CAPAs), and providing interim regulatory roles. The company also acts as the Person Responsible for Regulatory Compliance (PRRC) for medical device manufacturers under MDR and offers Data Protection Officer (DPO) services under GDPR for those processing personal health data.