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FDACE PRO Consultants specializes in consulting for CE Certification of Medical Devices. For companies requiring a CE mark for their product for exporting to the European Community, the Company assists with interpreting the standard and outlining the requirements for obtaining the CE Mark.
The Company gives complete guidance and advice from site/plant compliance to documentation e.g., Device Master File preparation, implementation of the system as per MDD/93/42, and training to staff of Medical Device manufacturers to obtain CE marking for their medical devices. The Company's completed and ongoing assignments for CE certification include Devices falling class I (Sterile), class II and type III.
DEVICE MASTER FILE PREPARATION
As part of the CE requirements, a Device Technical File has to be prepared to outline the safety requirements of the product and risk management. FADCE PRO will assist you in the preparation of the Technical File to meet the review of the third-party certification.
SELECTION OF CERTIFYING / NOTIFIED BODY
The CE Mark Certification requires a third-party review of the Technical file to assure conformity to the standard. FDACE PRO will assist you in the selection of this Certifying Body, prepare the application, and be present during the certification audit.
TECHNOLOGY & KNOW-HOW
The FDACE PRO undertakes Active Medical Device Manufacturing Projects. These include process setup at pilot scale and up-gradation to Plant scale, Production, establishing QA systems, and analytical methods/process development & validation.
Specialist consultants on EU regulations
Our two main service areas, medical devices, and cosmetics, generally require specialist consultation due to the complexities of regulations.
Our team of lawyers, chemists, pharmacists, and other experts collaborate to provide a combination of representative services, CE marking, and compliance consultation.
However, we also provide more extensive consultation on EU regulations for other finished products intended for introduction into Europe.
Our compliance frameworks and processes similarly focused on getting aspiring non-European exporters ready to expand into European markets.
Some examples of other sectors we consult for include:
Personal protective equipment
At FDACE PRO, we believe that the way we treat each other while striving to achieve our objectives is just as important as what we make. We believe in building productive, long-term relationships with clients and each other Challenging our teams
Demonstrating a 'can-do' attitude
Fostering collaborative and mutually supportive environment entrepreneurship.
FDACE PRO demonstrates leadership and a strong commitment to sustainable compliance and safety in the EU. As a company, we take pride in: Acting with an owner mentality.
Being passionate about what we do.
Seizing opportunities and welcoming responsibility
Being alert to change and meeting the challenges that arise from these changes in a quick and decisive manner
Providing both our clients and ourselves with a competitive edge Professionalism
At FDACE PRO, we deliver on our promises and pride ourselves on going the extra mile, adding value that goes beyond the usual standards. Our ways of working and making decisions, as well as our compliance with procedures, ensure we have the freedom to shape our future.
We learn by continuously developing and deepening our knowledge of our business and the skills of everyone in it. We learn by:
Listening to each other, clients and advisors
Sharing & capturing knowledge
Applying the lessons learned from successes and failures
Our leaders are accountable and take responsibility for their actions. They are also thoughtful and innovative. At FDACE PRO, we inspire trust by:
Matching our behavior to our words and taking responsibility for our actions
Collaborating in the best interests of our clients and acting as leaders
Believing that we all play a leadership role
In our business, leadership defined by courage and personal integrity, as well as having the vision and positive attitude to inspire and motivate others.
We believe that working with people from different backgrounds, cultures, and ways of thinking helps our teams grow into better professionals and leaders. As a company, FDACE PRO is committed to:
Valuing diversity and unique contributions
Fostering a trusting, open and inclusive environment
Treating each person in a manner that reflects our values
We believe in behaving with the highest levels of integrity – nothing is more important than our reputation. In a business that relies on integrity, honesty, and accountability, being trustworthy, honorable, and responsible is a fundamental part of who we are. Launch Your Product to EU Market
EU Product Registration
Guiding you through the compliance process and registering products to be made available on the EU Market.
Manufacturers that wish to make their goods available on the EU market may only Register (Notify) their products once they have demonstrated their compliance within a technical file per the applicable legislation(s).
Depending on the legislation, this may mean completing a Notification via a harmonized database such as EUDAMED (Medical Devices/In-Vitro Diagnostics) or CPNP (Cosmetic Product Notification Portal) only after the products have sufficiently demonstrated compliance with the applicable legislation.
Personal Protective Equipment
Introduction to Personal Protective Equipment in the EU Market
Specialized clothing such as goggles, gloves, helmets, or masks that intended to protect the wearer from inherent hazards has a broad spectrum of applications from dense machinery environments to sports. These hazards may include biohazards, heat, physical, electrical, heat, chemicals, or airborne.
Personal Protective Equipment Legislation
Until the publication of the Personal Protective Equipment Regulation 2016/425/EU on March 9, 2016, the subsequent two year transition period, the Personal Protective Directive 89/686/EEC, was the robust legal framework for medical devices.
While the Personal Protective Regulation 2016/425 repealed the PPE Directive 89/686/EEC with effect from April 21, 2018, Equipment that has a valid EC-type examination. Certificate issued, according to the old Directive, may still be placed on the market until the expiration date of the corresponding EC-type examination certificate (no later than April 21, 2023).
Any product placed and made available on the EU market (either through e-commerce or traditional retail) must comply with the Personal Protective Equipment Regulation 2016/425
Non-EU based manufacturers should appoint European Authorized Representative (EAR)
The manufacturer defined as:
any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark
Higher risk PPE (Category II & III) will require the intervention of a Notified Body to obtain the CE Mark
Products that fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines, or destruction of the products.
CE Certification - Medical Device CE Marking
CE Marking (CE Mark) is a mandatory requirement for medical devices to market in Europe. Medical Device category includes medical equipment, medical software, medical & surgical disposables, etc... CE Marking (CE Mark) is recognized worldwide as a symbol of quality. It consists of a CE logo and a four-digit identification number of the certifying notified body (if applicable).
For a Medical Device Manufacturer or Distributor, CE marking is the declaration that the product complies with all EU directives or EU regulations that apply to the medical device. CE marking does not imply that the product was made in the European Economic Area, but it states that the product is complying with the requirements of the European Economic Area.
By affixing the CE marking, the manufacturer indicates that he/she takes responsibility for the conformity of the product. If importers or distributors market the products under their own name (OBL), the responsibility is transferred to the importer or distributor.
In Medical Devices Directive (MDD), the medical devices are classified into four classes, class I, class IIa, class IIb, and class III. The certification of a Notified Body is not required for non-sterile and non-measurable medical devices of class I, but notified body certification is required for class I (s-sterile) and class I (m- measuring) devices.
FDACE PRO provides assistance from medical device classification through affixing CE Mark
Our services include
Medical Device Classification
Identification of MDD requirements
Identification of Harmonized standards
ISO 13485 Implementation
Identification of Notified BodyTechnical File preparation
technical File submission to Notified Body
Technical file re-submission
Assistance with Notified Body audit
Assistance in closing non-conformities
Affix CE Mark