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Swiss Bionic Solutions Certification Seminar

Swiss Bionic Solutions Certification Seminar. „Nothing is more powerful than an idea whose time has come“ Victor Hugo (1802 - 1885) French Author. Swiss Bionic Solutions Holding Switzerland. Distribution Subsidiaries. Organization. Trademarks worldwide License Rights Internet Rights.

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Swiss Bionic Solutions Certification Seminar

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  1. Swiss Bionic Solutions • Certification Seminar

  2. „Nothing is more powerful than an idea whose time has come“ Victor Hugo (1802 - 1885) French Author

  3. Swiss Bionic Solutions Holding Switzerland Distribution Subsidiaries Organization Trademarks worldwide License Rights Internet Rights Swiss Bionic Solutions Switzerland Swiss Bionic Solutions Germany SBS Academy Knowledge and Education Swiss Bionic Solutions USA Marketing International Swiss Bionic Solutions Canada Engineering Product Development Business Development International Swiss Bionic Solutions Asia

  4. Worldwide Expansion 2014 Target: 70% increase

  5. Growth of Representatives 2014 Target: 5000 LSC`s

  6. The SBS-Philosophy • The term “Lifestyle Consultant” which we coined is based on an integrated approach. The human organism is a part of the whole and therefore subject to natural laws. Based on biological laws, traditional knowledge and consideration of existing, scientific findings, we research, develop and offer high tech concepts worldwide that support the maintenance and improvement in the health of humans and animals. As a principle, we use bionics as our paradigm and our focus is solely on energetic, biological and physical methods of solutions.

  7. Magnetic Resonance Stimulation Systems (MRS-PEMF) • At this time the best, most comprehensive and most scientific documented application for an integrated approach for humans and animals are low-frequency, pulsed electro-magnetic fields. This fact is based on over 5000 years of experience and the knowledge of the necessity of this “elemental force”. SBS is the forerunner, trendsetter and market leader worldwide in the field of PEMF-systems for home applications.

  8. Where Are We Today? • In 1993 the first magnetic resonance stimulation systems for home use appeared on the market. • Until today there are only approximately 500.000 systems from various manufacturers in use • Approximately 60% of all users world-wide own systems from the MRS- series. • MRS-Systems are now in the 5th generation. 2014 ?? !!

  9. iMRS - A Medical Product • ?

  10. ??? • “ Medical Product “ does not mean.......... • That health care insurance will pay for it. • That a therapeutic success is guaranteed. • That it can be advertised without restriction. • The definition of a “Medical Product” is differentiated by the following interpretation: • Production/Manufacturing • Application Spectrum/Uses

  11. Medical Product -iMRS-Systems • Regulation within the EU - 93/42 EEC • Medical products are according the guideline 93/42/EEC which states that all single or connected instruments, apparatus, devices, software, materials, or objects including those designed for diagnostic and/or therapeutic applications and software intended for effective functioning of medical products which are designed by the manufacturer for the application on humans and animals for the following purpose: • Detect, diagnose, monitor, prevent, cure and alleviate diseases; • Detect, monitor, treat, alleviate or compensate injuries or disabilities; • Examine, replace or alter the anatomical composition or physiological procedure; • Contraceptions • And which states that those, whose regulatory main effects in or on the human body cannot be achieved by either pharmacological or immunological or metabolical methods , but whose effects can be supported by such methods.

  12. Medical Product - Production/Manufacturing • Essentially every Product contains a Risk! • In the area of medical product certification two objectives have to be met to assess the risk: • Product Safety = Which risks are associated with the product? • 2. Application Safety = Which danger/risks are associated with the practical and therapeutical use of the medical product?

  13. Medical Product - Guidelines Harmonized EU-Guidelines (already world wide adapted) Product Safety: IEC 60601-1 (electrical safety) IEC 60601-1-2 (electromagnetic compatibility) Conformity declaration of the manufacturer that these guidelines have been met = authorization to use the CE-logo on the product. This guideline is a prerequisite to distribute a medical product.

  14. Medical Product - Guidelines Harmonized EU-Guidelines (already world wide adapted) Production/Manufacturer Guidelines (DIN EN ISO): QM-System DIN EN ISO 9001:2008 (general) QM-System DIN EN ISO 13485 (Medical product) SBS complies with all these guidelines. Placing medical products in the market place: QM-System 93/42 EEC, Appendix VI - Section 3 is product related and complied with by SBS.

  15. Medical Product - Guidelines Conclusion: iMRS-Systems from Swiss Bionic Solutions comply with the following guidelines with respect to product safety and production guidelines: IEC 60601-1:1988 + A1: 1991 + A2: 1995, IEC 60601-1-2 (ed.2), extended CB-certificate for additional countries (USA, Canada, Australia), DIN EN ISO 9001:2008, DIN EN ISO 13485, 93/42 EEC Since 2012 an additional requirement for all certified medical products: IEC 14971 (risk analysis)

  16. Medical Product - Designation CE-Logo with 4 Digit Check Number This means that a particular named body is involved in the certification (manufacturing code = 4 digit number). The inclusion of this code is a requirement for medical products under 93/42 EEC.

  17. Medical Product - Duties of the LSC • Duties of a Certified Lifestyle Consultants: • Successful examination (mandatory) • Commitment to continuous education • Referral agent status (important for limited liability) • Duty to set up and initialize a medical product with the client (installation & activation document needs to be signed by the client and submitted by the rep to Swiss Bionic Solutions).

  18. Medical Advertising Law • The basic concept is founded in the attempt to protect people from illegal and misleading marketing propaganda. This law § 1, section 1 applies to: • Drugs • Medical Products • Products and procedures and processes, treatments and devices as well as medically not-prescribed plastic surgical procedures.

  19. Medical Advertising Law The medical advertising law may vary from country to country in its interpretation, at the heart of it is always the same principle: It is strictly prohibited to make any claims or promises with respect to cure/healing. (In fact only remedies can be advertised whose effects are geared to a specific illness and are documented and proven scientifically through accredited studies: randomized, placebo-controlled, double-blind).

  20. Medical Advertising Law The medical advertising law contains a number of indications which are prohibited from advertising and these are: Advertising for treatment to relieve or eliminate specific diseases in humans (example: reportable diseases, cancer etc) or animals (example: cancer, colic in horses and cattle). It is however allowed to advertise on a website, provided this website is only accessible to a group of experts (such as doctors).

  21. Medical Advertising Law • Medical products (specially magnetic-resonance-stimulation) and other natural products/procedures are subjected to restrictive advertising. The following are prohibited (outside of groups of experts): • Any form of healing promise. • Any statements with respect to diagnose, special treatments, alleviating, influencing and healing of specific indications (diseases). • Before/After Comparisons, if faked or untrue • Visually showing doctors or pharmacists • Expert opinion and endorsements from third parties

  22. Medical Advertising Law • Statements that elicit fear • Contests • The public advertising statement about the iMRS is therefore limited to common information about the general impact on the metabolism and the regulating and balancing characteristics supporting the treatment of numerous physical and mental dysfunctions. If in doubt it is always recommended to ask SBS prior to publicly advertising in any way (TV, radio, internet, print).

  23. Medical Advertising Law Vocabulary for Public Advertisement: NO: Therapy YES: Application or the new term „Session“ NO: Disease YES: Dysfunctions NO: Indication YES: Condition/State NO: helps with... YES: is used in support of... NO: Healing through... YES: improves overall condition NO: is used for... „Indication“ YES: is being used to support and in conjunction with... „Condition“ It is always a question of wording and phrasing!

  24. 10 Minute Break

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