7 steps for instant confidence
Step 1 for instant confidence: Look in a mirror
When you think you are ugly and want to hide your head in a paper bag you are unlikely to feel confident. However, if you are having an “ugly day” (or one of those “ugly years”), take advice from psychologist Nikki Owen: ‘When your eyes take in something that pleases you, your brain’s reward system is activated and you will see an almost instant improvement on your face’. So, the next time you look in the mirror focus on areas that you like about yourself. You’ll be feeling smoking within minutes ladies and gents.
Step 2 for instant confidence: Gay BFF
If you’re a woman, it turns out that self-confidence is all about the gay BFF. A study conducted by researchers from Mount Saint Vincent University in Nova Scotia, Canada and the University of Lethbridge in Alberta, Canada found that women who have a gay friend have better self-esteem when it comes to the way they look and their body confidence. Although the researchers weren’t entirely sure why women felt better about their bodies when they had a gay friend, some claim it is because gay men are far more generous when it comes to compliments and are skilled at giving ego massages.
Step 3 for instant confidence: Workout
Although pulling on your smelly training shoes and donning some not-so-flattering lycra doesn’t sound much fun when you’re curled up in bed or sprawled out on the sofa watching re-runs of your favourite TV show, a study seen in theJournal of Health Psychology says that even if you exercise for a little amount, on a regular basis, your mood improves. Therefore even if you don’t do a really intense workout, you can still reap the positive benefits of exercise and experience the perks of the mood boosting endorphins that exercise gives us.
Step 4 for instant confidence: Straighten up
When you were little you were constantly nagged by your parents and teachers to stand tall, stop slouching and sit straight. Does anyone do the same for you now? Although it would be a little annoying to have someone constantly telling you off for having bad posture, it turns out that it might make you believe in your own abilities a lot more. A recent study found that people who sat up straight and wrote down how qualified they were for a job believed in their abilities far more than those people who did the same activity, but who slumped over their desks. If you’re reading this now, sit up and improve your posture.
Step 5 for instant confidence: Cancel
Sometimes we hang out with people we don’t really like. People that moan, whine and bully their way through life, bringing everyone around them down into their pit of misery and self-loathing. Remember, you are under no obligation to see anyone who makes you feel bad. Although you shouldn’t abandon your friends and family when they are having a hard time, ask yourself how long they have been acting in this way and if it is really necessary. Are they being mean and belittling you? If you decide they’re being unfair and are affecting your confidence start to cancel on them and associate with people that reinforce your confidence and don’t bring you down.
Step 6 for instant confidence: Be a traveller
Why is it that when you travel everything seems interesting, fresh and intriguing? Everything seems better when you are away and you feel better too. Although we haven’t conducted any grand studies into this phenomenon, we have a strong suspicion that it’s all about the mindset. Being somewhere new does something to us that makes us relax, unwind and become less inhibited. Although getting away from the humdrum of your home life and routine helps you to do all of these things, it’s only your mindset that has actually changed. After all, you are still you. If you can try to adopt this travelling way of thinking in day-to-day life you’ll feel calmer, more relaxed and far more confident.
Step 7 for instant confidence: Think about love
Feeling loved is one of the best ways to boost your confidence, but what do you do if there’s no one around to tell you how much they care for you? Simple; just remember a time when you were shown a lot of love. Think of those birthdays when you were showered with gifts, or when you left your old job and were told how much you’d be missed. When you were ill or had a baby did you receive lots of concerned visitors and get sent lots of get well cards? Remembering moments like these will instantly boost your confidence because it shows that people love and care about you.
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Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.