Regulatory focus will be on the main components of the CREX System consisting of FixAid, RapAn and related Test devices. Based on CarpoNovum’s revised European classification decisions tree (February 2009), the devices are considered to be short term or transient surgical invasive devices i.e. Class IIa (while the Test device is a Class I product). USA (FDA) and China (S-FDA) apply the same definitions, but to secure the route to approval in China we are in the process to getting a definite statement from S-FDA. However we believe that the applications and S-FDA approvals is going to be a straight forward processes. In USA there are some late predicate devices, which will simplify the 510(k) process both for us as manufacturer and the FDA.
To facilitate further regulatory approvals and mutual recognition, we have decided to choose the “full quality system route” (compliance with EN/ISO/13485) for CE marking. We will also evaluate the first technical file to certify our compliance with MDD.
CarpoNovum is committed to providing medical devices and associated services that meet customers’ expectations and comply with relevant regulatory requirements.
CarpoNovum AB ensures that the established Quality Policy:
is appropriate for the purpose of the organization
includes a commitment to comply with the requirements and to maintain the effectiveness of the quality management system
provides a framework for establishing and reviewing quality objectives
is communicated and understood within the organization (all staff is trained in the quality policy) and is reviewed for continuing suitability
The current Quality Policy is stated as follows:
CarpoNovum is committed to;
- Compliance with applicable national laws, regulations and standards.
- Establish and maintain a QMS according to EN/ISO 13485
- Seek certification of its QMS
- Compile Technical files
- Establish contracts with main sub-contractors
- Securing suitability and an appropriate number of suppliers.
The Quality Policy is communicated to all employees during their introduction program.