ISO 13485 & EU MDR - Expert Advice Community

Defining and documenting authorities

I need to define and document authorities in regards to yes/no and accept/reject scenarios. My plan is to create an organizational chart, and also to update all job descriptions to include their immediate supervisor. Is that adequate, or do I need to create a flowchart for each process, showing who has authority at each stage? 

Need for meeting requirements per FDA 21 CFR

Our Company will NOT be making medical devices. Company will be making components for the medical industry (Lighting Lenses, Handles, Covers) - Will we need to meet requirements per FDA 21 CFR? 

CE marking

My question is about why companies are allowed to market/sell products before receiving a CE mark approval. In articles I have read it seems that CE marking is a requirement for selling medical devices in Europe however I am looking at a couple of companies that are selling without a CE mark, what is the reason for this? Also if companies do not need a CE mark approval then what is the benefit of going through the process of getting one?

Requirements for medical device implant

iso 13485 requirements medical device implant

IVD Smartphone glucometers

Hope you are doing safe, recently I joined an IVD startup manufacturing company, the product is Smartphone glucometers there is no predicate device in the market, now we are planning for ISO 13485, could you suggest to me what strategy should be followed for implementation & technical documentation.
Thanks.

ISO 13485 queries

Among the questions I have during the implementation of the QMS there are the following:

• The change control procedure does not seem to take in consideration the NBOG guidance or MDCG-13 or to advise the registrar.
• Is there a tri-party quality agreement between sterilizer/contract manufacturer/ legal manufacturer?
• Records retention seems always be for 2 or 5 years.  I couldn’t see anything for 10 years per MDR.
• Statistical procedure seems to be missing.

Defining quality objectives

Want to know about quality objectives. Do we need to define quality objectives every year? Department-specific quality objectives or product-specific?

Relation between Directive IVDR 98/79, IEC 64304, 62366 and ISO13485

The relation between Directive IVDR 98/79, IEC 64304, 62366 and ISO13485. Esepecially the documentation.