Cetry Services: QA & RA Support

Quality Assurance affects the entire company. Cetry is experienced in the field of medical materials/device manufacturing and development, regarding Quality Assurance (QA) and Regulatory Affairs (RA). From the cradle to the grave - from incoming raw materials to outgoing finished products - from concept to manufacturing - from complaint to customer satisfaction.
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Cetry is able to help with interim QA-management for companies that are temporarily without a QA director. We also help companies that have the intention of installing their first Quality Management System (QMS) or want to upgrade their existing system (e.g. to ISO 13485 compliance). General assistance can be offered e.g. in order to spread the work-load.

• Fill the gap - taking care of the daily routine within the current quality system
• Improvement of the Quality Management System (QMS)
• Implementation of an entirely new Quality Management System, e.g. for starting companies
• Sub-section management - e.g. quality engineering, quality system design, quality-based product development
• Assistance of current QA-management

European registration of medical devices is guided by the directives for Medical Devices (MDD), Active Implantable Medical Devices (AIMD), In Vitro Diagnostic Medical Devices (IVDD), their annexes and MEDDEVs. These guides reflect European legislation, which in turn is enforced by the Competent Authoroties (the EU nations) and delegated to commercial organizations that go by the functional name of "Notified Body".
Cetry is able to assist in product registration, e.g. by means of the following:

• Build of a Design History File (DHF) and Device Master File (DMF)
• Product claims definition
• Support regarding demarcation between medical and medicinal devices
• Assistance of working with the Essential Requirements List, ISO norms, pharmacopoeias
• Interaction with the Notified Body
• Guidance of audits from the Notified Body

Quality-driven manufacturing tends to balance between desired ease of production (speed) and process-output control (quality). There is always a natural tension between the Quality Assurance department and the Manufacturing department. The first wants more control, the second desires less paperwork. Essential is that both departments have one thing in common: Output of sellable products. That means that the products must function as claimed, they must be safe, and they must keep the customer satisfied. Keeping that in mind, Cetry can help you evaluate the production line, and separate necessity from perception. Think of:

• Analysis of manufacturing methods, regarding effectiveness and necessity of In-Process Control (IPC)
• Analysis of product Quality Control methods (QC) regarding effectiveness and necessity
• Analysis of Incoming Control (IC) of materials and manufacturing accessories regarding effectiveness and necessity
• Linkage of QC and IPC to risk management
• Screening and improvement of logging systems (forms and procedures)
• Analysis of calibration requirements (see section below)
• Definition and implementation of process validations
• Performance of a Failure Mode & Effect Analysis (FMEA)
• Analysis of workflow
• Assistance regarding definition and performance of equipment Installation Qualification and Operation Qualification (IQ/OQ)

Risk analysis is an extremely important part of risk management. The analysis helps identifying possible risks related to your products and manufacturing methods. It also serves to assess the possible impact of those risks. Risk management encompasses risk analysis, risk evaluation, risk reduction, and risk control. General guidelines are ISO 14971 (for medical devices) and the FDA Guidance for Industry - Q9: Quality Risk Management.
Cetry is able to assist in all fields of quality risk management. Think of:

• Definition / build of a risk analysis procedure
• Delivering expertise on risk items, especially on how to cope with too high residual risks (risk/benefit analysis)
• Assistance with performance of risk analysis in practice
• Sitting in as independent member during risk assessment sessions
• Linkage of product claims to potential risk
• Linkage of manufacturing criteria to potential risk
• Upgrading of the existing risk management system to ISO 14971
• Assistance in finding and implementing risk reduction measures
• Assistance in building a post-production risk monitoring procedure
• Assistance with embedding risk-driven quality assurance into the existing system

Keeping in touch with the field performance of medical devices is essential to risk containment. This requires feedback from customers and evaluation/interpretation of complaints and remarks. Incidents with your medical devices may have to be reported to the Competent Authority, and actions must be undertaken to prevent further similar incidents from happening.
Cetry can help in the following areas:

• Set up and implement procedures in line with MEDDEV 2.12-1: "Guidelines on Medical Devices Vigilance System"
• Set up and implement procedures for customer complaint handling
• Assist with difficult customer complaint cases
• Assist with evaluation and implementation of Corrective and Preventive Actions (CAPA)
• Assist with incident evaluation and reporting
• Link vigilance and risk management (ISO 14971 and/or FDA Q9)
• Link product claims to risk management and product control

Proper management of materials and manufacturing accessories is crucial to quality-driven manufacturing. What happens if the materials are not stored properly, what is properly? What happens if the purchaser had ordered cheaper materials that looked like the original (on paper)? What happens if materials are used that have not yet been tested at Incoming Control? Quality-driven materials management is there to prevent these and similar errors, in order to make sure that the right materials - in the right condition - are used at the right locations.
Cetry can help, e.g. in the following areas:

• Definition of purchasing and materials management routes
• Definition and implementation of Incoming Control (IC)
• Linkage of materials management to risk management
• Definition of storage requirements for incoming materials/accessories and outgoing finished products
• Set specifications of materials, to include storage and test requirements
• Department audit and training of personnel

Cetry is not accredited for ISO audits, neither is it a Notified Body. This means that ISO certification audits and CE audits need to be done by accredited and notified bodies. However, we are able to help within your organization, for instance by:

• Building/writing an internal auditing procedure/system
• Performing internal audits
• Writing an overall procedure for audits (internal and external)
• Assistance to the company during and after customer audits
• Assistance to the company during and after ISO audits
• Assistance to the company during anf after CE audits
• Assistance with supplier audits

Proper calibration of measuring devices and analytical methods is one of the key elements of controlled manufacture. Most problems are encountered when trying to interpret criteria for calibration: How accurate must the measuring device be? Why? Cetry can help you link calibration requirements to product claims, manufacturing validation, risk-reduction essentials, ISO norms (e.g. ISO 10012), etc. Items of interest are:

• Specification of correct criteria for calibration, including calibration frequency
• Linkage of calibration requirements to product risk analysis, as part of risk management
• Determination of what must and what must not be calibrated
• Linkage of calibration to incoming control of goods
• Validation of calibration methods (hands on)
• Setup of new calibration methods (hands on)
• Training