Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Failure to comply with FDA’s wishes landed three companies warning letters.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.
These three practical methods can help facilitate success.
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.