Close this search box.

The Importance of Regulatory and Quality Consultancy for Medical Devices from early stage idea

In today’s rapidly evolving healthcare landscape of medical device development, ensuring compliance with regulatory requirements and maintaining high-quality standards is paramount. Professional regulatory (RA- Regulatory Affairs) and quality (QA – Quality Assurance) consultancy services play a crucial role in guiding companies through the whole product lifecycle, from initial idea and R&D to market entry and post-market surveillance.

Regulatory and quality consultancy support services offer specialized expertise to navigate through the regulations governing medical devices. These services ensure that products meet the necessary standards set by bodies like the US-FDA (21CFRpart820), CE-MDR (MDR2017/745) and IL MOH-AMAR. The consultants help in crafting the medical device robust regulatory strategy ensuring compliance throughout the product lifecycle.

Consultants specializing in QA (Quality Assurance) and RA (Regulatory Affairs) provide invaluable support in establishing and maintaining a Quality Management System (QMS) and Quality System Regulations (QSR). They guide companies through the submission process to regulatory authorities, including EU-REP, EU Notified Bodies (NB), and the FDA, ensuring that all documentation and procedures are in line with regulatory expectations. All to shorten to minimum the TTM (Time To Market).

One of the critical steps in regulatory compliance is the classification of a medical device. Device classification determines the regulatory pathway, including the level of scrutiny and the type of pre-market submission required. Regulatory consultants assist in classifying devices according to various regulatory frameworks, such as the FDA’s class I, II, and III system, or the EU MDR’s Class I, IIa, IIb, and III system. Correct classification is essential to identify the necessary regulatory controls and submission requirements.

During the development process, regulatory and quality consultants offer R&D support, helping to integrate regulatory requirements from the outset. Establishing and maintaining a comprehensive risk assessment framework is critical. Consultants aid in implementing design and development controls, cybersecurity measures, and suppliers and purchasing controls, ensuring that all aspects of product development adhere to regulatory standards.

The transition from development to production, or Transfer to Production (TTP), is a critical phase where consultants ensure that the process is smooth and compliant. They assist in process verification and validation, guide how to conduct IQ/OQ/PQ and ensuring that manufacturing processes consistently produce products meeting all predefined criteria

Once the product is on the market, maintaining its quality and compliance remains crucial. Regulatory and quality consultants manage the changes (ECO and FCO), the Software upgrades, complaints handling, quality improvement initiatives, and conduct on going quality audits.

During the whole product life cycle, Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) will be supported by the consultants to address any identified issues, ensuring the product safety and efficacy.

Prior official inspections and regulatory reviews by FDA and NB, the consultant can perform mock audits to prepare companies for those visits.

In conclusion, the expertise of regulatory and quality consultancy services is indispensable for medical device companies as of their early stage of define the device IU (Intended Use).

For transparency, the writer is the medical regulatory and quality department manager at Hermon Labs. Hermon Labs is the leading accredited lab in Israel for medical devices tests together with its regulatory and quality consultancy allows the customers to receive end2end solution.

Skip to content