Manufacturers of medical devices and IVDs need to have documented controls of their product lifecycle and management. Compliance to ISO 13485 requirements means that you have a fully fledged quality management system in place, which ensures you have what you need to be compliant.
Compliance to this standard reaches all parts of the company and includes documented procedures and records the company must do. Requirements include: risk management, documentation control, supplier management, design and development processes, calibration and maintenance of equipment, audits, Human Resources,
Getting a quality management system off the ground can be a daunting task, but at Fieldfare we will make this journey as efficient as possible, leaving a system in place that becomes second nature to your company.
No two companies are the same, and therefore no two quality systems will be the same. At Fieldfare we will help implement policies and procedures that fit your company and its needs.
We will establish within your company an understanding of quality requirements, but most importantly the means of continuing compliance once your system is up and running.
We provide services to prepare documentation for new processes and records, get new procedures up and running and provide any necessary training.
At Fieldfare we have substantial knowledge and experience in the following areas.
- ISO 13485
- 21 CFR 820
- ISO 14971
- IEC 62304
Business Systems
Security of data and information within a company is becoming increasingly paramount especially with increasing need to provide security and privacy to consumer and patient data.
ISO 27001 is the only international standard that fully defines the requirements of an information management system and is pragmatic in that it takes a risk-based approach to implementation. The standard spans across the entire company including security of physical premises, IT infrastructure, cryptography, remote working, access control, business continuity, human resources and supplier control.
The benefits of implementing ISO 27001 are huge, including protecting your companies from security threats, avoiding potential regulatory fines and maintaining your company’s reputation.
At Fieldfare we provide services to prepare documentation for new processes and records, get new procedures up and running and provide any necessary training.
Get in touch to see how we can support you.
