Quality Management Systems
Audits and inspectionsQFI offers a wide and comprehensive range of audit and inspection services to the medical device sector operating a fully documented process
AuditusQuality First International provides: Assessment of product design, calculations, working drawings, control systems, equipment specifications
CE mark programmeCE marking is a declaration by the manufacturer that a product satisfies the appropriate provisions of the relevant legislation in Europe. The CE marking
ClassifyCLASSify allows professionals in the medical device sector and other interested observers to classify products or interrogate the Class of a particular
Medical Device regulatory support and standards complianceQFI assesses any existing Quality Management System (QMS) documentation for compliance with regulations and standards and prepares a comprehensive
Post-market surveillance ProgrammeManufacturers often underestimate post-market surveillance requirements due largely to imprecisely defined legislation and guidelines, a situation
Private label own brand manufacture ProgrammeManufacturers often underestimate post-market surveillance requirements due largely to imprecisely defined legislation and guidelines, a situation
Quality management systemThe majority of device manufacturers must implement a Quality Management System to satisfy the country where they market their product
QMS Advisory serviceThe majority of device manufacturers must implement a Quality Management System to satisfy the country where they market their product.
UKCA MARK SERVICEThe UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market
US FDA ClearanceQuality First International provides: Designation and classification of your device Register your establishment Preparation of Premarket Notification 510(k) submissions
Audits and inspections
Audit of goal-oriented QMS and other systems is offered to every size of manufacturer, distributor, private label and other economic operators also to supply chain – from raw material vendors, sub-tier suppliers and full contract manufacturers. Types of audit conducted include product and production/process, completed according to client or QFI procedures.
QFI performs government-standard inspections, ranging from Establishment inspection conducted to FDA inspection guides and conformity assessment to EU Competent Authority and Health Canada standard.
Additionally, QFI offers services to assess critical sub-contractors and crucial suppliers according to Commission Regulation 2013/473 (EU) and associated Market surveillance regulations.
QFI’s high-calibre technical specialists conduct product audit and assessment exceeding Notified body standard, specialising in high-risk and forefront product; QFI also conducts EU design-examination assessments, including on combination products, devices containing or derived from animal/ human tissue and other class III products; product technology and special process audits.
Additionally, QFI conducts labour standards assurance system (LSAS) audit, QMS, scientific, technical and regulatory audits for due diligence purposes plus MDSAP inspections.
- Assessment of product design, calculations, working drawings, control systems, equipment specifications and Quality System against International and Harmonised European Standards
- Verification of conformity of relevant documents against the appropriate international and Harmonised European standards, Consensus and other recognised Standards
- Examination of Technical Documentation according to relevant national and international Regulations
- Verification that inspection, supervision, test and document control satisfy production process Requirements
QFI assesses any existing Quality Management System (QMS) documentation for compliance with regulations and standards and prepares a comprehensive remedial plan to bring the system into compliance. This can include all contributing subcontractors, including any declared responsible on a device label are subject to audit against the requirements of the conformity assessment procedure of the principal manufacturer and is conducted in several phases.
QFI helps to conduct internal audits when:
- The scope of the assessment surpasses the abilities of the Notified Body
- A corporation wishes to outsource internal audit resources
- An internal audit programme needs external support
- Compliance verification is desired
- Conformity Assessment Procedures (CAP) are required for integration into a corporation
- Technology audit is desired
- Due diligence is required to the highest standard, including start-up and blue-chip
QFI auditors will:
- Conduct exhaustive audits and inspections according to client company procedures or our internal QMS audit procedures
- Include technical assessment of product, process and service functions
- Ensure the audit is unfettered unlike Notified Body and other Conformity Assessment Body audits
- FDA and Competent Authority inspections, etc
- MDSAP inspection
- Evaluate regulatory compliance
- Identify any gaps that exist between the relevant standards and the processes implemented
- Create a remedial action plan arising from audit findings and examination of supporting documentation
- Formulate recommendations and instructions to implement changes
- Improve the overall efficiency of your Quality Management System
Quality First International performs regulatory compliance audits and inspections to levels expected and practised by Governmental organisations (notably the Competent authority UK (MHRA), FDA and European Competent Authorities) and surpass Notified Body scrutiny. We offer outstanding external resources in support of medical device manufacturers, vendors, and distributors (internal) audits. Our team of technically competent and experienced product specialist auditors bring to the auditing process exceptional scientific, technical medical device regulatory, organisational and Quality System knowledge.
Auditus is particularly useful:
When an audit is undertaken to verify that the manufacturer has:
- Conclusively demonstrated full application of regulations and standards appropriate to the intended geographical marketplace
- Appropriate infrastructure and resources
- Appropriate product life-time design control
- Adequate means of identifying and reporting alleged adverse events
- Adequate Technical Documentation to support the CE mark, FDA approvals, Health Canada approvals, etc
When Expert Witness evidence is necessary as part of Due Diligence or preparations in defence of possible regulatory enforcement.
QFI performs medical device system compliance audits against:
- US regulations
- UK medical device regulations
- European medical devices Directives
- Canadian regulations
- Australian regulations
- EN ISO 9001 et seq
- EN ISO 13485
- Due diligence for mergers and acquisitions
- Meticulous scrutiny in defence of regulatory enforcement
- Quality System provisions
- Production facilities
- Technical review of production
- Subcontractor’s premises
- Final product inspection
- Testing techniques
- Product design
CE mark programme
CE marking is a declaration by the manufacturer that a product satisfies appropriate provisions of the relevant legislation in Europe. The CE marking demonstrates that a manufacturer has implemented appropriate European Regulation and Directives and the relevant authorities have authorised access to the European market.
For medical devices whether your business is a large blue-chip organisation, SME or start-up company, QFI can guide and assist with the many steps to attain CE Marking whereby we can assist in numerous ways, notably:
- Medical device classification
- Appropriate Notified Body selection
- Communication with Competent Authority where necessary
- Essential Requirements Compliance
- Identify applicable harmonised standards and help ensure conformity with them
- Support implementing and maintaining ISO 13485 and ISO 9001 quality systems
- Construct labelling, packaging, brochure and Instructions for Use
- Conduct hazard evaluations, risk assessment and management
- Performance evaluation design and management
- Clinical investigation design and management
- Vigilance Procedure and Post Market Surveillance development and execution
- Produce Design Dossiers where necessary
- Act as an Authorised Representative
- Improve and compile the entire CE Technical file
- Expedite submissions to the relevant authorities
- Register medical devices with the appropriate Competent Authority
- Provide on-site regulatory support during Conformity Assessment by Notified Bodies including EC design-examination
QFI has significant experience in bringing a wide range of products to the European market, including:
- Cardiovascular devices
- Orthopaedic devices
- Active and active implantable devices
- TSE and animal tissue-derived products
- Medical-electrical devices
- Devices containing radioactive material
- Borderline devices
- Nanotechnology devices
- Wireless devices
- Medical device software including stand-alone and Cloud
- Bluetooth devices
- In vitro diagnostic products
- Drug-device combination products
- Wound healing products
- Continence devices
- Regenerative medicine
- Breast implants
- Personal protective equipment
- Cosmetic products
- Other permanent implants
- Cognitive psychology
Additionally, we can produce high-calibre usability and human factors engineering files and evidence, support user and post-market studies and evaluations, as part of structured surveillance programmes.
QFI also conducts detailed medical device risk analysis to exerting standards, complying with leading standards and practices, safety and reliability engineering and health service standards.
CLASSify allows users to determine the correct EC Product Class (commonly referred to as CE Class or Class) of a medical device, quickly and accurately. Our service was developed with the knowledge of the European Commission but does not constitute an endorsement of the website opinions expressed by us or other users, further, the Class determined and referral to European Official text and does not constitute opinion or judgement by the European Commission.
CLASSify constitutes additional armamentarium to the regulatory professional seeking to determine, confirm or simply check the Class of a medical device to be placed on the Market. With added ease of viewing information in graphical and textual mode, plus the ability to search for the Class of precedent devices already CE Marked, our website will be your primary resource when classification or re-classification is necessary.
Using our unique, intelligent Classification Chart, we offer our members the ability to classify their medical devices in a way previously unheard of. The chart utilises knowledge of the classification rules according to Annex IX from Council Directive (93/42/EEC) to determine what EC Product Class your medical device belongs to. Once you complete the classification of your device, a Classification Report will be available for your device which you can download as PDF. Saving you time and effort, CLASSify will quickly become your primary resource when classification or re-classification is necessary.
- Saves you time, money and possibly improves the quality of your own research.
- CLASSify provides 24-hour, online access to a powerful classification portal.
- Efficient, cost-effective and affordable… Why not use CLASSify?
Medical Device regulatory support and standards compliance
Post-market surveillance Programme
QFI has planned and implemented post-market surveillance, post-market clinical follow-up and device tracking for medical device manufacturers and distributors for several years. With extensive experience supporting manufacturers as authorised representative, managing a wide variety of activities ranging from corrections and removals, product recall, notification to treat or warn, safety alerts, etc, QFI have achieved considerable know-how and aptitude in supporting clients seeking practical post-market experience monitoring programmes.
QFI have created programmes that enable clients to fulfil American, British and European legislation (as well as many other international jurisdictions), transform guidelines into effective practices and where contracted, even allow clients to outsource such operations to third parties.
Private label own brand manufacture Programme
Quality management system
With our technical expertise, accuracy and confidentiality we have helped a wide range of companies devise and implement Quality Management Systems that satisfy MHRA, US FDA, EU regulations, TGA Australia, Health Canada and other international regulations to allow legal placement of a product on the particular market. QFI has helped organisations gain access to specific regulatory domains regardless of location through:
- Creation and implementation of Quality Management Systems (QMS) satisfying Council Directives 93/42/EEC and 98/79/EC, Regulations (EU) 2017/745 and (EU) 2017/746, EN ISO 13485 and EN ISO 9001. Regularly completed in less than three months, often include comprehensive technical documentation for all device classes, preparation and submission of documents to the Competent Authorities, and fine tuning of the Quality Management System
- Creation and implementation of the US Code of Federal Regulation – Title 21 (21 CFR) Quality Management Systems (QMS) required for US FDA clearance. QFI regularly prepares and submits US FDA 510(k) and Premarket Approval (PMA) submissions on behalf of clients worldwide.
- Creation and implementation of hybrid Quality Management Systems (QMS) designed for dual- or multiple jurisdictions, eg simultaneous satisfaction of US FDA, and European Community regulations allowing the client to achieve FDA clearance and legal market placement in the European Community within time and budgetary constraints
We have also produced QMS to enable checks to fulfill a variety of other countries, including: Brazil, Mexico, Middle- and Far-East, etc.
QFI only implements original, custom-written Quality Management Systems. We do not re-use templates. All procedures and record formats are prepared specifically for each organisation using only direct observation of client practice and applicable standards as input. QFI provides skilled guidance and direct assistance to clients during Notified Body and other audits or Competent Authority and US FDA inspections. We have an exemplary record in this capacity. To date, no QFI-implemented Quality Management System has ever failed initial assessment or given rise to a non-compliance report (483 under US FDA 21 CFR) culminating in decline of registration or approval. Further, our clients determine the degree of assistance necessary from a simple review of documentation to complete preparation and implementation undertaken entirely by QFI Technical Specialists.
Although we customise our solutions for every client, our Quality Management Systems comply with the following:
- EN ISO 13485
- FDA Good Manufacturing Practice (GMP)
- Canadian Medical Devices Regulations
Further, every Quality Management System prepared by Quality First International has passed EN ISO 13485 audit first time, fulfilling sound basis for subsequent registration, authorisation and licence.
QMS Advisory service
UKCA MARK SERVICE
The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market (England, Wales and Scotland) since 1 January 2021. The UKCA mark is not recognised in the EU, EEA or Northern Ireland and does not substitute for CE marking, so relevant products continue to require CE marking for sale in these markets.
QFI is increasingly aware of manufacturers failing to fulfil their obligations under the recent changes to the UK medical device legislation. Manufacturers relying on CE marking conformity assessment, including technical documentation, are advised to rectify any deficiencies or incoherence urgently and to implement the requisite documented processes and procedures. QFI is adept at improving technical documents and documented controls to assist manufacturers in this.
QFI’s UKCA mark service assesses the preparedness of manufacturers’, distributors’ and other UK economic operators’ systems, conformity and evidence against applicable regulations, including all UK Statutory Instruments and other legislative acts. We formulate effective implementing programmes, and produce bespoke, compliant processes and procedures to effect compliance in your company.
Where instructed, QFI is able to integrate and implement comprehensive, documented systems solutions within your QMS or other management system.
US FDA Clearance
- Designation and classification of your device
- Register your establishment
- Preparation of Premarket Notification 510(k) submissions
- Complete Product Development Protocols
- Secure Investigational Device Exemption (IDE)
When entering the US marketplace, a medical device manufacturer must subject his medical device to the general controls of the Federal Food Drug & Cosmetic (FFD&C) Act which are contained in the final procedural regulations in Title 21 of the Code of Federal Regulations Part 800–1200 (21 CFR Parts 800–1299). Essentially, the manufacturer must first designate the product as a medical device or in vitro diagnostic for example and ensure that it must be regulated by the Center for Devices and Radiological Health (CDRH). Next the device must be classified into one of three classes, identifying the level of regulatory control. The classification of the device will identify, unless exempt, the process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must follow in order to obtain FDA approval.
QFI has directed many companies through the US FDA process. Our Technical Specialists are well versed in FDA requirements and adept at developing the data and information necessary to obtain FDA clearance as follows:
- Designate and classify your device
- Register your establishment
- List your device
- Obtain Premarket Approval where necessary
- Prepare Premarket Notification 510(k) submissions where a predicate device exists on the US market
- Verify that the predicate device meets the appropriate criteria, where necessary
- Complete a Product Development Protocol
- In the case of Investigational Device Exemption (IDE) regulation, manage clinical trials to eventually obtain marketing clearance
- Secure Investigational Device Exemption approval as required
- Conduct a Hazard Evaluation
- Prepare the Safety and Efficacy summary
- Assist in adhering to appropriate labeling regulations
- Communicate with the FDA Office of Device Evaluation to determine any special requirements
- Concerning the device in question
- Satisfy the postmarket surveillance controls, including the Quality System (QS) or Good Manufacturing Practices (GMP)
- Prepare, if necessary, responses to the FDA’s request for additional information
- Report adverse events following Medical Device Reporting (MDR) regulations
- Provide on-site regulatory support during Establishment or compliance inspection by US FDA
Furthermore, Quality First International can help you respond to a FDA Form-483 or Warning Letter from the US FDA. Usually received after an on-site audit by the FDA with a list of deficiencies determined by the inspection, you must respond in writing with a detailed action plan in response to each point made in the letter, providing a timeline to correct the issue. Quality First International can support corrective actions to address any issues identified by the audit and help clients prepare an effective response to the Form-483 or FDA Warning Letter.